Clinical Trials Updates

NewsBot · Dec 17, 2024

The Role of Extrinsic Foot Muscles Chances in Determining the Risk of Diabetic Foot Ulcer

Brief Summary
Many foot and lower limb disorders resulting from diabetes, such as deformity, muscle weakness, reduced range of motion, stiffness of connective tissue, amount of oxygenation, functional capacity, poor balance and coordination, can potentially be corrected or prevented with specific interventions (15). It is important to diversify assessment methods for the development and elaboration of prevention strategies. Rapid, low-cost and detailed evaluations provide good planning of treatment. According to the International Diabetic Foot Study Group (IDFG) scale used to determine the risk of diabetic foot ulcer, it is thought that performing a plantar pressure analysis of a patient with diabetes to determine the people who do not have foot ulcers but are at risk, knowing the difference in the amount of muscle oxygenation of the muscles around the foot and ankle with healthy people and the change in muscle elastic properties will be important in terms of preventing the occurrence of diabetic foot ulcers and determining the changes of the treatments applied in the lower extremities.
Click to expand...

NewsBot · Dec 28, 2024

Evaluation of Left Ventricular Function After Treatment of Diabetic Foot Ulcers Using Longitudinal Strain Echocardiography

Brief Summary
Early detection of heart failure as a macrovascular complication of DM offers the best chance of cure in these patients. Nowadays, the most common method for detecting heart failure is measuring left ventricle ejection fraction (LV-EF), by echocardiography. Despite the easy application of LV-EF, it remains normal in early stages of cardiac disease and it's considered as heart failure with preserved LVEF (HFpEF). We hope that, Strain monitoring as a new method enables us to detect the early minimal changes in myocardium.

The aim of study evaluate the effect of treatment of diabetic foot ulcers in improving heart function by strain echocardiography than conventional transthoracic echocardiography in Assiut university hospital.
Click to expand...

NewsBot · Jan 15, 2025

Effect of Music During Toe Amputation

The aim of this randomized controlled intervention study aims to investigate the impact of music played during toe amputation on patients' anxiety, pain, sense of safety, and fear of surgery.

The study will be carried out with two groups: The control and the intervention groups with 60 participants for each group. While the control group participants will receive standard care, the intervention group participants will listen to selection of Sufi music during the whole amputation procedure in addition to standard care.
Click to expand...

NewsBot · Jan 24, 2025

The Effect of Education on Patient Care Outcomes in Individuals With Diabetic Foot Ulcer

Brief Summary
The aim of this study is to determine the effect of Social Cognitive Learning Theory-based education on patient participation, self-efficacy and wound healing in individuals with diabetic foot ulcers. The research was conducted with 52 patients (25 intervention and 27 control) with Wagner 2 diabetic foot ulcers at Gülhane Training and Research Hospital between January and September 2024.
Click to expand...

NewsBot · Feb 12, 2025

Outcome After Radial Pressure Wave Therapy in Plantar Fasciitis. (RPWT)

The goal of this observational study is to explore potential associations between baseline patient characteristics (such as age, body mass index, and baseline pain intensity) and clinical outcomes in patients with plantar fasciitis undergoing radial pressure wave therapy (RPWT). The study includes male and female adults aged 18 to 60 years.
Click to expand...

NewsBot · Feb 12, 2025

Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis

This study evaluates the feasibility and safety of using Lipiodol (ethiodized oil) as an investigational embolic agent for treating pain caused by plantar fasciitis. Participants will undergo a minimally invasive procedure called plantar fascia embolization (PFE) to reduce inflammation and pain in the affected area. The study aims to assess changes in pain levels, foot function, and any potential side effects over a six-month follow-up period.
Click to expand...

NewsBot · Feb 16, 2025

Use of Extracellular Vesicles (EV) for Diabetic Foot Ulcers (EVDFUUJCTC)

Diabetes Mellitus is a common chronic medical condition that requires complex care strategies. Treatment includes methods to reduce glycemic burden and maintain glycemic control in the patient to prevent symptoms of hyperglycemia and reduce microvascular complications. In the case of patients with diabetes mellitus, wound healing, skin re- epithelization and skin integrity restoration are compromised, leading to chronic cutaneous ulcers such as diabetic foot ulcers. As much as 15% of all diabetic patients manifest diabetic foot ulcers. Moreover, 84% of all diabetes related lower leg amputations are anticipated to the result of diabetic foot ulcers. Compromised chronic cutaneous ulcer healing may result from cytokines, growth factor deficits, and insufficient angiogenesis process.
Click to expand...

NewsBot · Feb 16, 2025

The Effect of Message Framing in Diabetic Foot Self-Management

This study aims to assess how effective gain- and loss-framed messages are in improving diabetic foot care behaviors and increasing self-efficacy levels compared to routine foot care messages.
Study Design:
A randomized controlled trial with three groups:
Experimental Group 1 (Gain-Framed): Participants receive gain-framed messages emphasizing the benefits of proper foot care.
Experimental Group 2 (Loss-Framed): Participants receive loss-framed messages highlighting the risks of inadequate foot care.
Control Group (Routine Messaging): Participants receive standard foot care messages without specific framing.
Participants:
Diabetic patients recruited from Experimental Group 1, Experimental Group, and Control Group 3. Inclusion criteria include adults diagnosed with diabetes who are at risk for diabetic foot complications.
Intervention:
Over a period of three months, participants will receive WhatsApp messages three times a week.
Gain-Framed Messages: Emphasize positive outcomes, such as preventing foot ulcers by wearing appropriate footwear.
Loss-Framed Messages: Highlight negative consequences, such as the increased risk of foot infections from improper foot care.
Messages will include supportive images and videos to enhance engagement and understanding.
Outcome Measures:
Primary Outcomes:
Foot Care Behavior: Assessed using The Foot Care Behavior Scale. Self-Efficacy: Measured by the Diabetic Foot Care Self-Efficacy Scale Secondary Outcomes: Comparative effectiveness between gain-framed and loss-framed messages.Long-term behavioral changes post-intervention.
Significance:
This study seeks to determine the most effective messaging strategy to promote diabetic foot care, potentially informing future interventions to reduce the incidence of diabetic foot complications.
Click to expand...

NewsBot · Feb 16, 2025

Assessment of Serum Magnesium Level with Diabetic Foot Ulceration in Type II Diabetes Associated with Diabetic Nephropathy Patients

Magnesium (Mg), is the fourth most common cation in the body, with an essential role in fundamental biological reactions, whose deficiency provokes biochemical and symptomatic alterations in the human organism. This ion is now established as a central electrolyte in a large number of cellular metabolic reactions, including DNA and protein synthesis, neurotransmission, and hormone receptor binding. It is a component of GTPase and a cofactor for Na+/ K +-ATPase, adenylate cyclase, and phosphofructokinase. Magnesium is a cofactor in more than 300 cellular enzymatic systems and has a key role in cellular metabolism; the recognition that Mg deficiency or excess may be associated with significant clinical consequences has resulted in an increased interest in the utility of serum Mg measurement.
Diabetes mellitus (DM), characterized by metabolic disorders related to high levels of serum glucose, is probably the most associated disease to Mg depletion in intra and extra cellular compartments. In several studies reduced magnesium concentrations have been observed in diabetic adults. Hypomagnesemia has been related as a cause of insulin resistance, also being a consequence of hyperglycemia, and when it is chronic leads to the installation of macro and microvascular complications of diabetes, worsening the deficiency of Mg. The association between diabetes mellitus and hypomagnesaemia is compelling for its wide ranging impact on diabetic control and complications. Hypomagnesaemia has been linked to poor glycemic control, coronary artery diseases, hypertension, foot ulceration and diabetic neuropathy . Nerve Conduction Test (NCS)is the gold standard test that should be performed to confirm the presence of neuropathy to determine it's severity and to differentiate other causes of neuropathy from diabetic neuropathy.
Click to expand...

NewsBot · Mar 12, 2025

Efficacy of Tropical Sertaconazole Nitrate 2% Vs Clotrimazole 1% for Tinea Pedis

This randomized controlled trail study will be carried out on OPD patients in the Department of Dermatology, Jinnah Postgraduate Medical Center. Institutional Ethical committee permission will be obtained and clinical trial registration number (CTN) will be obtained for the study. Written consent will obtained from all the participants of the study.

All the diagnosed patients of Tinea Pedis who will meet the selection criteria will be enrolled and will be educated regarding the study. Participants will be randomly allocated in into two groups utilizing envelop method; patients of Group-A will use topical Sertaconazole 2% and patients in Group-B will use Clotrimazole 1%.

Randomization: Random number sequence will be generated on computer by a simple randomization schedule. Each randomization number will be sealed in an opaque envelope with a serial number on it. The patient with a known serial number opened the corresponding envelope to be informed of the assignment.

Treatment: After cleaning the identified lesions, the patients will topically self-apply the both products/creams using a cotton swab applicator, where the applied amount will be able to make the lesions be covered with a thin layer of medication. Both the creams will be applied topically twice daily for 4 weeks.

Patients will be followed up weekly for clinical improvement and side-effects of therapy upto 4 weeks of the treatment. At final follow up (after 4 week of treatment), the patients will be evaluated by all clinical investigations and microscopic examination (10% potassium hydroxide) of a skin scraping from site of the lesion. Adverse effects of the drugs among all patients will also be recorded. The photograph of the lesions taken before treatment and at the end of the study will be used for assessing the clinical improvement of the cases.

Detailed questionnaires will be followed regarding demographic and clinical characteristics like age, BMI, symptoms and co morbidities etc. Proper selection criteria will be used to control any biasness. Efficacy will be reported as per operational definition. In case of, topical therapy will be terminated and the concerned patient will be switched over to an oral antifungal drug at the discretion of the dermatologist. Any adverse events during the study will also be reported.
Click to expand...

NewsBot · May 24, 2025

HeEL Pain Pathways Feasibility Study (HELPP)

Brief Summary
At the moment, no-one is sure what the best way to treat heel pain is. The purpose of this research is to try out some study methods to prepare for a future clinical trial, that will assess how helpful combining different treatments are for people with heel pain (plantar fasciitis). At this stage, the aim is only to test the study processes and ask for feedback - that is why this is called a feasibility study. No experimental techniques or devices will be tested. All of the treatments in the study are routinely carried out in NHS clinics, but participants will be allocated to different combinations of treatments.

Each participant will be asked to complete questionnaires and a diary for around six months in total. Some people will also be invited to take part in an interview or focus group discussion.

Detailed Description
This single-centre study will test the feasibility of using a SMART design to provide tailored treatment pathways for people with heel pain. The study will investigate areas of uncertainty relating to the feasibility of a future full-scale SMART study. Key objectives are to assess whether the research design is feasible (including whether enough people can be recruited), and to determine whether the proposed adaptive intervention pathways are acceptable to patients and NHS staff.

50 people with heel pain will be recruited from referrals received by the Podiatry department. Participants will be randomly assigned to two groups initially - half will have a virtual consultation with a podiatrist; the other half will receive a self-help video. After following the advice at home for at least 4 weeks, anyone (in either group) who has not responded to treatment will be offered an assessment in an outpatient clinic. They will then be randomised equally again to receive either an orthotic device (shoe insole) or a course of 'Shockwave therapy' (using a non-invasive device to deliver ultrasound to the injured area).

As well as collecting Patient Reported Outcome Measures (PROMs) for a total duration of 6 months for each participant, process evaluation methods (interviews and focus groups) will be used to talk to patients. They will be asked about their experiences of adaptive intervention pathways and of participating in the feasibility study. The researchers will also interview staff involved in trial design and delivery (clinical members of the study delivery team) about similar topics from a different perspective. Progression criteria will be used to help decide whether to continue with the plan to run a full-scale trial to test effectiveness of the treatment pathways.
Click to expand...

NewsBot · May 28, 2025

Footwear Difference in Sports Use in Runners With Functional Equinus

Brief Summary
Observational study on Nimbus shoes for daily training with 8mm drop and designed for heavier than normal weight. Shoe weight is 300g with highly structured buttress and upper with internal heat-sealed midfoot for greater lateral stability. This is a Novablast shoe with a mixed profile for training and competition with 8mm drp and higher midfoot compression range with less lateral containment.
Click to expand...

NewsBot · May 30, 2025

Randomized Controlled Trial of Custom Foot Orthoses for Chronic Forefoot Pain

Chronic metatarsalgia (CM) causes significant pain and disability, affecting quality of life. Foot orthoses (FOs) including medially wedged designs with a metatarsal pad decrease excessive plantar pressure under the metatarsal heads, which is a known risk factor for developing CM. This FOs model may be effective in diminishing pain and improving function in these individuals. Thus, the objective of this trial is to compare the effects of medially wedged FOs with a metatarsal pad and sham FOs on pain and foot function in individuals with CM.

This participant- and assessor-blinded superiority randomized controlled trial (RCT) with two parallel groups will be conducted in Trois-Rivières, Canada. Seventy-two participants with chronic metatarsalgia (CM) will be recruited from the Université du Québec à Trois-Rivières outpatient podiatry clinic and via social media invitations. The participants will be randomized into intervention (customized FOs) or control (sham FOs) groups and will be evaluated at baseline and after 6 and 12 weeks, for a total duration of participation of 4 to 5 months (from the first contact until the last data collection). The primary outcomes will be: (1) "pain" subscale of the Foot Function Index and (2) mean pain during walking for the most painful foot during the past week. The secondary outcomes will be: (1) Global rating of change, (2) the 5-level EQ-5D (Health-related quality of life) and (3) Foot Function Index (disability and activity limitation subscales).

The medially wedged FOs with a metatarsal pad are expected to provide a greater reduction in pain and improvement in foot function compared to the sham FOs. This trial will help guide FOs prescription recommendations for managing foot pain in individuals with CM in the future.
Click to expand...

NewsBot · Jun 4, 2025

Efficacy of Corrective Rubber Insoles in Healthcare Professionals With Foot Overpronation

Foot hyperpronation is a common postural condition that can lead to pain, deformities (such as hallux valgus), and muscular issues. This problem is especially relevant among adults who spend long hours standing, such as healthcare workers. Custom-made foot orthoses with a medial wedge have proven effective in improving comfort and correcting certain biomechanical alterations, even in asymptomatic individuals.

The study described has two main objectives:

to validate the Italian version of the Foot Health Status Questionnaire (FHSQ), already validated in English and Spanish, by assessing its reliability and reproducibility as a tool to measure foot health.
through a pilot study, to analyze the effects of using specific professional footwear in healthcare workers with hyperpronation, evaluating perceived benefits in terms of pain reduction and postural improvement.
Click to expand...

NewsBot · Jun 4, 2025

Evaluation of Toe Separators in Foot Health (STEP-IN)

This pilot observational study investigates the effects of standard toe separators on foot health in asymptomatic individuals. It aims to evaluate their impact on intermetatarsal spacing, plantar pressure distribution, digital circulation, and user comfort. Through pre- and post-intervention measurements using tools like thermography, gait analysis (Zebris), and the Foot Posture Index, the research seeks to determine whether these commonly used orthotic devices provide measurable benefits or pose risks. The study ultimately contributes to evidence-based podiatric care and public health education.
Detailed Description

This research project titled "Evaluation of Toe Separators in Foot Health: A Pilot Observational Study (STEP-IN)" explores the biomechanical and physiological effects of standard, commercially available toe separators on healthy individuals without pre-existing podiatric conditions.

Given the growing popularity of these devices on social media and among the general public-often promoted as tools for correcting deformities, relieving plantar pain, or improving foot posture-this study aims to objectively assess their actual benefits and limitations using scientific methods.

The study employs a pre-post observational design involving 40 adult volunteers. A comprehensive analysis is conducted before and after the application of toe separators, focusing on several key variables:

Intermetatarsal angles and spacing measured through imaging (ultrasound or X-ray).

Gait and plantar pressure distribution assessed with the Zebris system.

Digital circulation evaluated visually and via thermographic imaging.

Foot posture assessed using the validated Foot Posture Index (FPI-6).

Comfort perception measured through a Visual Analog Scale (VAS).

Participants are evaluated during static stance and dynamic walking conditions to determine how the devices affect natural biomechanics. Data is analyzed statistically using SPSS and JASP to compare pre- and post-intervention results, applying appropriate tests based on normality assumptions.

Ethical approval was obtained from the Ethics Committee of the Universidad Católica de Valencia, and all participants provided informed consent.

This project aims not only to inform podiatric practice but also to serve as a foundation for future, larger-scale clinical trials. Additionally, it seeks to counteract misinformation by offering evidence-based insights into a widely used but poorly studied orthotic product.
Click to expand...

NewsBot · Jun 5, 2025

Factors Affecting Response to Extracorporeal Shock Wave Therapy in Plantar Fasciitis: A Cross-sectional Clinical Stud

Brief Summary
Heel pain is a problem that affects daily life activities and quality of life. Extracorporeal shock wave therapy (ESWT) is a treatment used for heel pain. However, some people do not benefit from ESWT treatment. The aim of this study is to determine the factors that affect the response to ESWT in the treatment of heel pain.
Detailed Description
Plantar heel pain is one of the reasons that affect daily life activities. There are many treatment methods for this. Extracorporeal shock wave therapy (ESWT) is one of them. However, some patients do not respond to ESWT treatment. In this study, patients were divided into 2 groups as those who did not respond to ESWT treatment in terms of pain (less than 50% decrease in pain level) or those with recurrence of pain and those who responded to treatment. Patients who had passed 3-6 months after ESWT constituted the study groups. These two groups will be compared in terms of age, gender, occupation, weight, height, Body Mass Index (BMI), side: right / left / bilateral, calcaneal angle, Meary angle, presence of spur on X-ray (size in mm if present), dorsiflexion angle degree, plantar fascia thickness with ultrasonography, tibial / plantar nerve conduction study evaluated with electroneuromyography, Visual Analog Scale, Heel Sensitivity Index and Foot Function Index.
Click to expand...

NewsBot · Jun 10, 2025

Systematic Ultrasound in the Initial Assessment of Ankle Sprain (PFEEC)

Ankle sprains are the most frequently encountered trauma in emergency and general medicine. Lateral ankle sprain injuries have the highest relapse rate of all musculoskeletal injuries of the lower limbs. Optimal initial management is essential for a successful return to previous condition, with the aim of preventing chronic ankle instability, chronic pain, stiffness or recurrence. One of the 13 physicians at our facility routinely performs an ultrasound routinely scan during the second consultation to assess the severity of the sprain. We would therefore like to evaluate whether the performance of this examination at the time of clinical reassessment is associated with a better prognosis at 3 months post-trauma.
Click to expand...

NewsBot · Jun 10, 2025

Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis, a Randomized Feasibility Trial. (HomePDT_Nails)

This randomized feasibility trial aims to determine the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) using a novel LED device (L-Home PhoD) for the treatment of onychomycosis.
Click to expand...

NewsBot · Jun 17, 2025

Effects of Custom-Designed 3D-Printed and CAD-CAM Insoles on Individuals With Flexible Flatfoot (Insoles)

Brief Summary
This study aims to investigate the effects of custom-designed insoles produced using Computer Numerical Control (CNC) and 3D printers on plantar pressure distribution analysis, foot posture, plantar force distribution, foot pain, and satisfaction in patients diagnosed with pes planus.
Detailed Description
This randomized controlled trial evaluates the impact of custom-designed insoles, created using Computer Numerical Control (CNC) and 3D printing technologies, on plantar pressure distribution, foot posture, pain, and user satisfaction in individuals with flexible pes planus. The study targets adults aged 18-55, with specific clinical and postural inclusion criteria, and excludes individuals with biomechanical or neurological confounders.

Participants are randomly assigned to one of two intervention groups using a simple randomization method: one receiving CNC-produced insoles and the other 3D-printed insoles. Assessments are conducted before and after 8 weeks of insole use, employing standardized tools such as the Foot Posture Index, subtalar angle measurement, plantar pressure analysis, and satisfaction/function questionnaires. The primary aim is to explore comparative biomechanical and subjective outcomes to inform best practices in orthotic design and application.
Click to expand...

NewsBot · Jun 25, 2025

Big Toe Muscles Strengthening Exercises With and Without Neuromuscular Training Among Runners

The big toe in relation to the other toes is responsible for a much greater percentage of foot and body stabilization as well as forward propulsion. Big toe muscles play a very significant role in the toe off phase during the locomotion, increasing the final push off from the ground during activities like walking, running and jumping. Also have a role in maintaining medial arch of the foot. Marked evidence shows that neuromuscular training programs are effective for improving measures of performance. Comprehensive neuromuscular training programs designed for young women may significantly increase power, strength, and neuromuscular control. So, this study will determine the effects of big toe muscles strengthening exercises with and without neuromuscular training among runners.

This study will be a randomized clinical trial conducted at Pakistan sports board and coaching center Lahore and runners club in Lahore. Only female runners aged between 18-30 years having at least 1 year experience will be recruited in study. The participants will be randomly divided by simple random sampling into two groups. One group will perform the big toe muscles strengthening exercises with neuromuscular training and the other group will perform the big toe muscles strengthening exercises without neuromuscular training. The effects of Strengthening exercises of both the groups will be accessed on speed, power and agility of runners. Toe strength will be accessed by toe-hip dynamometer, Speed by 30 m sprint test, power by vertical jump, and agility by T-drill agility test at the start, and at the end of study duration. Statistical analysis will be performed using SPSS-26 providing a comprehensive approach to investigate the effects of bio toe muscles strength with and without neuromuscular training on speed, agility and power among runners.
Click to expand...

NewsBot · Jun 30, 2025

Effect of Phonophoresis Versus Iontophoresis in the Treatment of Perimenopausal Plantar Fasciitis

Brief Summary
The purpose of the study was to investigate the effect of phonophoresis versus iontophoresis on plantar fasciitis in perimenopausal women.
Detailed Description

Collagen plays a critical role in determining the tensile strength of connective tissue. During the perimenopausal transition, the overall quantity of collagen decreases; however, there is a relative increase in type I collagen compared to type III collagen. This shift contributes to increased tissue stiffness. Research indicates that estrogen has a protective effect on muscles and fascia, preventing fibrogenesis. Consequently, as estrogen levels decline during perimenopause, fibrogenic activity may increase. In addition, reduced estrogen levels are associated with enhanced elastin degradation, leading to diminished tissue elasticity and reduced recoil capacity.

This degradation of connective tissue is considered a primary cause of plantar fasciitis, which results from collagen breakdown in the plantar fascia at its origin-the calcaneal tuberosity of the heel-and surrounding fascial structures.

When plantar fasciitis develops in perimenopausal women, it can significantly disrupt daily activities. Many women experience fallen arches and severe irritation, with pain affecting functions such as standing, walking, climbing stairs, and working. This functional impairment can lead to emotional consequences, including depression.

Given these challenges, there is a pressing need to identify new, alternative, and cost-effective methods for managing and treating this condition. This study examined the effectiveness of phonophoresis and iontophoresis in treating plantar fasciitis in perimenopausal women. The findings aimed to contribute valuable knowledge to the field of physical therapy and offer practical solutions for women suffering from this condition.
Click to expand...

NewsBot · Jun 30, 2025

EFFECTS AND FEASIBILITY OF PHOTOBIOMODULATION AT 830 NANOMETERS IN THE TREATMENT OF DIABETIC ULCERS: A RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL

Brief Summary
Diabetic foot ulcers (DFU) are among the late complications of DFU, defined as skin lesions that involve the dermis to deeper structures, such as muscles and bones. Although preclinical studies have demonstrated the effects of GaAs 830 nm in diabetic wounds, no clinical studies have been performed, revealing the need for more in-depth analyses to identify the effects and ideal parameterization of PBM with GaAs 830 nm wavelength in the treatment of diabetic ulcers, improving quality of life, as well as to understand the therapeutic feasibility, time required for healing and recurrence rates of these lesions. Experimental, randomized, controlled, double-blind study, with blinding applied to the evaluator and participants. A total of 136 volunteers will be recruited for the research, carried out at the Integrated Center of Medical Specialties (CIEM) - Polyclinic. LLLT GaAs 830nm will be used with three dosages of low, medium and high intensity (4 J/cm², 8 J/cm², 12 J/cm²). The study will have three intervention groups using LLLT with GaAs 830nm and a control group, in which LLLLT will be performed with a GaAs 904nm wavelength and a dose of 10 J/cm², according to Saura et al (2024). This study was approved by the local Research Ethics Committee (Opinion 7,488,044), conducted in accordance with the Declaration of Helsinki and in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines.
Click to expand...

NewsBot · Jul 2, 2025

Foot Positions Affect Basketball Players With Flatfoot

Brief Summary
This study investigated the effect of various initial foot positions on knee and ankle proprioception, balance, dynamic balance, vertical jump, and electromyographical muscle activity in basketball players with FF.
Detailed Description
Objective: To investigate the effect of various initial foot positions on knee and ankle proprioception, balance, dynamic balance, vertical jump, and electromyographical muscle activity in basketball players with FF.

Methods: Eighty-four basketball players with chronic ankle instability were distributed to three groups (28 with flexible FF, 28 with rigid FF, and 28 without FF). The outcome measures will include static and dynamic balance, knee and ankle proprioception, vertical jump, and electromyography (EMG) of ankle muscles (including gastrocnemius (GE), soleus (SOL), tibialis anterior (TA), and peroneus longus (PL) muscles)
Click to expand...

NewsBot · Jul 9, 2025

Effect of Kinesiotaping on Lower Limb Kinematics and Functional Related Outcomes Among Female Athletes With Chronic Lateral Ankle Instability

The current study aims to measure the effect of adding kinesiology tape to ankle mobilization with movement with calf muscles flexibility exercise on dorsiflexion range of motion, dynamic balance, lower limb kinematics, and self-reported physical function versus mobilization with movement, calf muscles flexibility exercise, and placebo kinesiotapping in female basketball players with unilateral chronic lateral ankle instability
Detailed Description
Chronic ankle instability affects up to 70% of individuals with lateral ankle sprain, causing pain, recurrent sprains, and instability. This condition significantly impacts physical and financial welfare, necessitating effective treatment techniques. Ankle injuries are common in healthy, active individuals, affecting women more frequently than men. These injuries can cost healthcare systems around the United States dollars 6.2 billion in high school athletes in the United States and euro 208 million in the Netherlands annually. Most rehabilitation protocols focus on isolated interventions, neglecting the potential benefits of combined strategies. This study contributes to evidence-based practice by adding to existing knowledge on chronic ankle instability rehabilitation practices and supporting healthcare professionals in implementing effective treatment plans. Combined intervention strategies may enhance dorsiflexion range of motion, lower limb kinematics, ankle stability, postural control, and athletic performance, reducing time away from sports.
Click to expand...

NewsBot · Jul 25, 2025

Effects of Strength Training on the Plantar Flexors' Properties After Achilles Tendon Rupture

Among the injuries that affect the Achilles tendon, rupture is one of the most frequent. This injury can generate functional, neuromuscular, and tendon deficits that can last for long periods or even be permanent. In the long term (i.e., more than a year after the injury), individuals present functional impairments related to the lower limb, deficits in the capacity to produce muscle force, as well as higher levels of muscle activation (as a compensatory response). Such changes may be due to injury adaptations in the plantar flexor muscles' architecture, which may have shorter, more pennate fibers, leading to reduced muscle thickness. Furthermore, the Achilles tendon may be elongated, with a greater cross-sectional area, presenting lower stiffness and quality (i.e., lower Young's modulus). Strength training can play an important role in recovering from Achilles tendon ruptures, as it promotes functional, neuromuscular, and tendon adaptations that can minimize deficits caused by the injury. However, there is a gap in the literature regarding strength training, as well as the dose vs response relationship, regarding functional, neuromuscular, and tendon adaptations after Achilles tendon rupture. Thus, the aim of the present study is to compare the effects of a strength training program of different intensities on plantar flexors' functional, neuromuscular, and tendon outcomes after Achilles tendon rupture. Men aged between 20 and 50 years old who suffered a total unilateral rupture of the Achilles tendon between one and five years after the rupture will be included in the study, as well as healthy men who did not suffer the rupture (control group). Participants who have suffered an Achilles tendon rupture will undergo a progressive lower limb strength training program twice a week for a total duration of 12 weeks, which will be randomized between two groups: low intensity (G55 - 55% of 1-RM) and moderate intensity (G70 - 70% of 1-RM). The following outcomes will be evaluated: a) Achilles tendon's morphological (length and cross-sectional area), mechanical (force-elongation relationship and stiffness) and material (stress-strain relationship and Young's modulus) properties; b) triceps surae muscles' morphological (architecture [fascicle length, pennation angle and thickness] and quality [measured by echointensity and specific tension]) properties; c) ankle functionality (maximum height in the heel raise test); d) the plantar flexors' force production capacity (peak and rate of torque development in different joint positions); e) the plantar flexors' muscle voluntary activation; and f) triceps suraes' neuromuscular capacity (i.e., recruitment curves). Assessments will be performed at two times (pre-training; and after 12 weeks of training [post-12]) through functional tests, ultrasound techniques, isokinetic dynamometry, electromyography, and percutaneous electrical stimulation. An intraclass correlation coefficient will be used to verify the test-retest reproducibility of ultrasound measurements. The Chi-Square test will be used to compare the level of physical activity (pre-training) between the groups. The results of the intervention will be expressed using descriptive statistics (mean, standard deviation, and standard error). The normality and sphericity of the data will be tested using the Shapiro-Wilk and Mauchly tests, respectively. A generalized estimating equation, followed by Bonferroni post-hoc, will be used to compare the effects of groups (G55 and G70) and times (pre-training, Post-6, and Post-12). A one-way ANOVA, followed by a Bonferroni post-hoc, will be used to compare the control group participants' limbs with the healthy and injured limbs from both intervention groups (G55 and G70) in the Pre and Post-12 times. The effect size will be estimated for each outcome. All statistical analyzes will be performed using SPSS software.
Click to expand...

NewsBot · Aug 13, 2025

One Cause of Heel Pain is Plantar Fasciopathy (PF). In Most Cases, a Heel Spur is Frequently Present Alongside PF. We Aim to Evaluate the Efficacy of Corticosteroid Injection and Radiofrequency Ablation, Along With Tissue Elasticity Assessed by Ultrasound, in Patients With Chronic Pain (≥6 Months).

Heel pain is common among adults. One cause of heel pain is plantar fasciopathy (PF). In most cases, a heel spur, a bony prominence that extends into the plantar fascia, is frequently present alongside PF. First-line treatments include pain-relieving drugs, home exercises, heel support peds, and physical therapy. However, some patients can't get relief from these therapies, and the pain persists beyond six months. This situation is referred to as refractory chronic PF. Local treatments applied via skin puncture such as anti-inflamtory injection and destruction of nerves carrying pain signals to brain are warranted in these cases. We aim to evaluate the efficacy of corticosteroid injection and radiofrequency ablation, along with tissue elasticity assessed by ultrasound, in patients with chronic pain (≥6 months).

The goal of this clinical trial is to determine which treatment-corticosteroid injection or radiofrequency thermal thermocoagulation-is more effective for treating plantar fasciopathy in adults. It will also learn about the effects of the treatments on the properties of the heel tissue using ultrasound. The main questions it aims to answer are:

Do corticosteroid injections and radiofrequency thermal thermocoagulation have the same efficacy on pain and functionality for both short- and long-term? Do corticosteroid injections and radiofrequency thermal thermocoagulation similarly affect heel tissue? The researchers will investigate which of the corticosteroid injection and radiofrequency thermocoagulation is more effective for
Detailed Description

Plantar fasciopathy (PF) is one of the most common causes of foot pain, accounting for approximately 10-15% of all cases. The plantar fascia originates from the calcaneus on the plantar surface of the foot and inserts into the proximal phalanges. It becomes tense while standing and provides support to the medial longitudinal arch. Although the pathophysiology of PF is not fully understood, repetitive mechanical overload is believed to cause microtears, particularly at the medial origin of the plantar fascia. Subsequent inflammation and degeneration may become chronic, and excessive traction at the medial calcaneus can lead to the formation of a bony outgrowth called a calcaneal spur. This bony protrusion may increase pain by causing inflammation, nerve compression, and atrophy of the heel fat pad. Approximately 67% of patients with PF present with a calcaneal spur.

Typically, patients complain of heel pain upon taking their first steps in the morning or after periods of rest, and during weight-bearing activities. On physical examination, tenderness is usually observed along the medial aspect of the heel, and pain is exacerbated with toe extension. Diagnosis is generally based on clinical history and physical examination. Ultrasound imaging can aid in diagnosis due to its rapid application and bedside availability. Conventional ultrasonography may reveal thickening of the plantar fascia, perifascial edema, hypoechoic areas within the fascia, and the presence of a calcaneal spur.

Shear wave elastography (SWE) is a modern, non-invasive ultrasound modality that measures tissue stiffness and elasticity. Measuring the stiffness of the plantar fascia using SWE, along with B-mode parameters, can facilitate diagnosis. Moreover, it allows monitoring of structural changes in the fascia following treatment.

Treatment options for PF include non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy, orthotics, night splints, corticosteroid injections (CSIs), platelet-rich plasma injections, extracorporeal shockwave therapy, and radiofrequency ablation (RFA). While corticosteroid injection may provide short-term pain relief, it is associated with risks, including alteration of connective tissue microstructure and fat pad atrophy. In RFA, continuous electrical current generates heat, leading to the destruction of nociceptive free nerve endings in the target area. RFA has been successfully used for decades in the management of lower back pain, head and facial pain, sympathetic chain ablation, and joint pain. Various studies have also supported its efficacy and safety in treating PF.

The primary aim of this study is to compare the effectiveness of RFA and CSI using the Foot Function Index (FFI) score at 6 months. The secondary aim is to assess pain scores and structural changes in the plantar fascia using SWE.
Click to expand...

NewsBot · Aug 15, 2025

Central Sensitization and Nociplastic Pain in Pes Planus

Background:

Pes planus, commonly known as flatfoot, is a condition characterized by the collapse of the medial longitudinal arch of the foot. While some individuals remain asymptomatic, many experience foot or leg pain, walking difficulties, and functional limitations. In some cases, symptoms persist despite adequate conventional treatment. This suggests that central pain mechanisms, such as central sensitization and nociplastic pain, may contribute to ongoing symptoms. These mechanisms involve changes in the central nervous system that amplify pain perception and can occur even in the absence of active tissue damage. Understanding these mechanisms in pes planus may help guide more targeted and effective treatment strategies.

Purpose:

The aim of this multicenter cross-sectional study was to determine the prevalence of central sensitization and nociplastic pain in individuals with clinically diagnosed pes planus and to compare the findings with age- and sex-matched healthy controls.

Methods:

Between November 2024 and May 2025, a total of 107 patients with pes planus and 107 healthy controls were recruited from three medical centers. Participants completed validated Turkish versions of the Visual Analog Scale for pain intensity, the Foot Function Index for functional limitation, the Pain-DETECT questionnaire for nociplastic pain symptoms, the Central Sensitization Inventory for central sensitization, the Hospital Anxiety and Depression Scale for psychological distress, and the Short Form-12 for quality of life. Data were analyzed using comparative statistical tests and multiple linear regression models to identify factors associated with nociplastic pain and central sensitization in the pes planus group.
Detailed Description

Pes planus, also referred to as flatfoot, is a common musculoskeletal condition characterized by the flattening or collapse of the medial longitudinal arch of the foot. It affects a considerable portion of the adult population and may be associated with foot pain, functional impairment, and reduced quality of life. In many patients, pain symptoms persist despite adequate structural correction and conventional treatments such as footwear modifications, orthotic support, exercise, or anti-inflammatory medications. This persistence suggests that central mechanisms of pain processing may be involved.

Central sensitization is a phenomenon in which the central nervous system exhibits heightened responsiveness to sensory input, resulting in amplified pain perception even in the absence of ongoing tissue injury. Nociplastic pain is a relatively new classification describing pain arising from altered central nociceptive processing without clear evidence of tissue damage or nerve injury. Both mechanisms are increasingly recognized in chronic musculoskeletal disorders, yet they have been underexplored in individuals with pes planus.

This multicenter cross-sectional study was designed to investigate the prevalence of central sensitization and nociplastic pain in adults with clinically diagnosed pes planus and to compare these findings with healthy controls matched for age and sex. Participants were recruited from three medical centers between November 2024 and May 2025. Inclusion criteria required adults aged 18 to 65 years with lower extremity pain lasting at least six months and a diagnosis of pes planus confirmed by a physical medicine and rehabilitation specialist. Healthy controls had no history of foot or leg pain or relevant musculoskeletal disorders.

All participants completed standardized and validated assessment tools, including the Visual Analog Scale for pain intensity, the Foot Function Index for foot-related disability, the Pain-DETECT questionnaire for nociplastic pain features, the Central Sensitization Inventory for signs of central sensitization, the Hospital Anxiety and Depression Scale for psychological distress, and the Short Form-12 for quality of life. Demographic and clinical information was also recorded.

Statistical analyses compared results between the pes planus and control groups and examined correlations among pain severity, functional impairment, central sensitization, nociplastic pain, and psychological measures. Multiple linear regression models were used to identify independent predictors of nociplastic pain and central sensitization in the pes planus group.

The findings of this study are intended to improve understanding of the complex pain mechanisms associated with pes planus and to highlight the potential need for multidisciplinary management approaches that address central pain processes and psychological factors alongside conventional biomechanical interventions.
Click to expand...

NewsBot · Sep 3, 2025

Footwear and Brain Activity in Children (FooTBAC)

Childhood is a critical period for neuromotor development, during which footwear may influence both gait biomechanics and the integration of sensory and motor control processes. This study will aim to analyze brain activity in children aged 6-7 years while walking under three conditions: barefoot, in barefoot-style (minimalist) shoes, and in conventional shoes with heel drop.

A quasi-experimental, repeated-measures study will be conducted, in which each participant will complete a 10-meter walking task under the three conditions, in randomized order. Brain activity will be recorded using a 14-channel wireless electroencephalography (EEG) system (Emotiv EPOC X), and relative spectral power (theta, alpha, beta, gamma) as well as Theta/Alpha and Beta/Alpha ratios will be calculated.

Statistical analysis will include global and regional comparisons (frontal, temporal, parieto-occipital), assessment of hemispheric asymmetry, and multivariate analysis. The study is expected to provide novel information on how footwear type may modulate cortical organization during children's gait, with potential implications for pediatric footwear design and clinical recommendations.
Click to expand...

NewsBot · Sep 6, 2025

Zadek Osteotomy for Treatment of Haglund's Syndrome

Haglund's syndrome is an abnormality of the bone and soft tissues in the foot. An enlargement of the bony section of the heel (where the Achilles tendon is inserted) triggers this condition.

symptom includes insertional Achilles tendinopathy (IAT), The patient with HS often has a red, irritated, painful heel. And they often complain the enlargement of the posterior heel, which make it more difficult to footwear or sport

Zadek described the Zadek Osteotomy option for the treatment of Haglund's syndrome This operation can change the calcaneus' anatomical length and elevate the distal insertion point of the Achilles tendon

- It is a prospective case series study that will be done in Orthopedics and Traumatology department of Sohag university hospitals on patients suffering from Haglund's syndrome and treated by Zadek osteotomy
This study aims to evaluate short term clinical, radiological and functional outcomes of Zadek osteotomy for treatment of Haglund's syndrome
Click to expand...

NewsBot · Sep 8, 2025

The Relation Between Plantar Pressure Distriution on the Foot and The Way of Carrying Backpack in Students Between 12 to 18 Years

What is this study about? This is an observational study that investigates how different ways of carrying a school backpack affect the pressure distribution on the soles of the feet (plantar pressure) in adolescents.

The main questions it aims to answer are:

Does carrying a backpack on one shoulder (unilaterally) change the pressure on the bottom of the foot compared to carrying it on both shoulders (bilaterally)?

Does carrying a backpack change the amount of the foot that touches the ground (contact area)?

Are there differences in foot pressure between the right and left foot based on how the backpack is carried?

Researchers compared four different carrying conditions to see their effects:

Carrying no backpack.

Carrying a backpack on both shoulders.

Carrying a backpack on the right shoulder only.

Carrying a backpack on the left shoulder only.

Who participated? The study included 92 healthy adolescent students (32 boys and 60 girls) from Mansoura City, Egypt. Their ages ranged from 12 to 18 years old, they had a normal Body Mass Index (BMI), and had no existing postural or musculoskeletal problems.

What did participants do?

Participants in the study were asked to:
Click to expand...

Have their height, weight, and posture checked to ensure they were eligible.

Stand and walk barefoot on a special computerized pressure-sensitive mat (a Foot Scan Plate System).

Perform these standing and walking tasks under the four different backpack conditions listed above. The backpack was always loaded to weigh 15% of the student's body weight.

What did the study find?

The key findings were:

How you carry the backpack affects how much of your foot touches the ground. Carrying a backpack on one shoulder (especially the right) increased the contact area of both feet on the ground, both while standing and walking.

The average and maximum pressures on the soles of the feet did not change significantly. Regardless of how the backpack was carried, the intensity of the pressure under the feet remained relatively the same in these healthy adolescents.

Overall balance was maintained. Even though the carrying method changed how the feet contacted the ground, the body compensated well, and no significant imbalance in pressure between the right and left foot was found during walking.

What does this mean for patients, families, and healthcare providers?

For Teens and Families: This study highlights that how you carry your backpack matters for your foot mechanics. While a brief change may not cause immediate pain, consistently carrying a backpack on one shoulder can alter your posture and gait. It is best to use both shoulder straps to distribute weight evenly and promote healthy body alignment.

For Healthcare Providers: This research provides evidence that backpack carriage method is a modifiable factor influencing plantar loading patterns in adolescents. Assessing a patient's backpack habits could be a useful part of evaluating complaints of foot, knee, or back pain. Educating patients and families on symmetrical load carriage and proper backpack weight (≤15% of body weight) is a valuable preventive strategy.

The bottom line: While the body can adapt to short-term uneven loading, making a habit of carrying a backpack on both shoulders is the best practice for supporting healthy foot pressure distribution and overall posture in growing adolescents.

NewsBot · Sep 8, 2025

Gait Pattern Analysis After Arthroscopic Treament of Osteochondral Defects of Talus

The study will investigate alterations in post-surgical gait patterns among patients who have undergone all arthroscopic microfracture and biological scaffold implementation surgery for the osteochondral lesions of talus. The gait biomechanics of patients scheduled for surgery will be assessed preoperatively using pedobarographic analysis. Subsequent changes in walking biomechanics will be evaluated and interpreted at the 6th postoperative months. Consequently, the impact of the all arthroscopic treatment of osteochondral lesions of talus on walking will be documented.
Click to expand...

NewsBot · Sep 19, 2025

Effect of Foot Core Control Training on Dorsiflexion Function and Gait Biomechanical Characteristics of Patients With Chronic Plantar Fasciitis

The pain and abnormal gait postures observed in CPF patients may be associated with impaired foot function. However, few studies have examined the dorsiflexion function of the big toe in CPF patients, and the effectiveness of foot core control training in alleviating pain and improving gait remains unclear. Restricted movement of the metatarsophalangeal joint (MTPJ1) may severely compromise foot function, leading to gait pattern alterations and subsequent instability. To address this, our study aims to improve symptoms, functional outcomes, and gait through foot core control training interventions. We recorded kinematic parameters and biomechanical data during the foot's plantar phase at toe-off before and after functional training for CPF patients. Comparative analysis between intervention groups revealed whether foot core control training can effectively enhance big toe dorsiflexion function and gait biomechanics in CPF patients. This research clarifies the therapeutic efficacy of foot core control training for CPF patients.
Click to expand...

NewsBot · Oct 30, 2025

Expanded Access Program Evaluating SkinTE in the Treatment of Wagner 1 Diabetic Foot Ulcers

The purpose of this EAP is to provide access to SkinTE® for patients with Wagner I Diabetic Foot Ulcers (DFUs). SkinTE® is an autologous investigational product created from a healthy full-thickness skin harvest. SkinTE is applied directly to the wound with the goal of promoting healing.

In addition to providing treatment, the program will collect safety and efficacy data. This data will help us understand the potential risks and benefits of SkinTE® when used in a real-world setting. PolarityBio® provides research funding to the study site to support data collection.
Click to expand...

NewsBot · Dec 5, 2025

Evaluation of a New Postoperative Dressing After Hallux Valgus Surgery (psmt3D)

Hallux valgus, commonly known as a bunion, is a condition where the big toe deviates toward the other toes, often causing pain, difficulty with footwear, and decreased quality of life. Surgery can correct the alignment of the big toe, but during recovery the toes must be supported in the correct position so that the improvement is maintained. After this surgery, a spacer is usually placed between the big toe and the second toe for several weeks while the soft tissues heal.

Standard spacers made of folded gauze are not custom-shaped to each patient's foot, which may lead to discomfort, skin irritation, or misalignment of the other toes. To address these limitations, a new custom-made spacer has been developed using 3D printing technology. This spacer is individually designed to match each patient's foot shape, with the goal of improving comfort and maintaining proper toe alignment throughout the healing phase.

This clinical study will evaluate whether the custom-made 3D-printed spacer is better tolerated by patients than the traditional folded-gauze spacer and whether it helps maintain the corrected position of the big toe after surgery. The study will include 40 adults undergoing bunion surgery. Participants will be randomly assigned, like drawing lots, to receive either the 3D-printed spacer or the standard gauze spacer. Both spacers are applied externally during surgery and are worn continuously for five weeks as part of routine postoperative care.

Participants will attend follow-up visits at 1 week, 3 weeks, and 5 weeks after surgery. At each visit, comfort, pain, and any skin irritation caused by the spacer will be evaluated. At the final visit, toe alignment will be assessed using routine weight-bearing X-rays and clinical examination. No additional medical procedures or radiation will be required beyond standard care.

The hypothesis of this study is that the custom 3D-printed spacer will be well tolerated and will help maintain better toe alignment compared with the standard folded-gauze spacer. If successful, this personalized approach may improve recovery and patient satisfaction after bunion surgery.
Click to expand...

NewsBot · Dec 20, 2025

The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, Biomechanics, and Pain Intensity

We hypothesize that the addition of a unilateral neutral shoe insert combined with standard physical therapy (PT+SI) will have greater improvements in pain and function at 12 weeks and 6 months compared to physical therapy with sham inserts (PT+Sham) and physical therapy (PT) alone. In addition, we hypothesize that the addition of a neutral shoe insert in the involved limb will immediately improve biomechanics and pain with the single-leg stance test.
Click to expand...

NewsBot · Dec 20, 2025

Foot Core Stabilization Exercises Vs. Shockwave Therapy for Pain, Strength, and Function in Plantar Fasciitis

This study aims to evaluate the effectiveness and feasibility of two distinct approache extracorporeal shock wave therapy and foot core stabilization exercises in the treatment of plantar faciitis (PF) by comparing their impacts on pain, muscle strength, and functionality. The study seeks to better understand the role of innovative exercise protocols in addressing biomechanical imbalances and the contribution of ESWT to biological healing mechanisms. The anticipated results are expected to provide evidence-based treatment approaches that can enhance the quality of life in individuals with PF, guide clinical applications in physical medicine and rehabilitation, and strengthen the position of these treatment methods within the broader healthcare system. Moreover, the findings may benefit a larger patient population by improving the management of PF.
Click to expand...

NewsBot · Dec 20, 2025

P : Ingrown Toenail Patient I : Bird Flap Surgery C : Noel Winograd Method O : Recurrence, Complications, Functional Outcome, Pain, (ITN)

The treatment of ingrown toenails is highly diverse, with numerous surgical techniques described in the literature alongside conservative approaches. The primary goals of all these surgical methods are to reduce recurrence rates, improve patients' quality of life, and achieve favorable cosmetic outcomes. In this study, we aim to compare the recently introduced Bird Flap, a modified Winograd technique, with Noel's technique and the classic Winograd method in terms of recurrence rates, patient quality of life, cosmetic outcomes, and postoperative pain.
Click to expand...

NewsBot · Dec 20, 2025

Effects of Short Foot Exercise on Knee Pain, Muscle Tone, Balance, and Quality of Life in Flexible Flatfoot Patients

This study was a clinical trial to investigate the effects of Short Foot Exercise (SFE) and standard physical therapy on knee muscle tone, knee pain and function, balance ability, and quality of life in adults with flexible flat feet and knee pain.
Click to expand...

NewsBot · Dec 29, 2025

Prediction Model for the Risk of Developing Foot Ulcers in Diabetes

Introduction Foot ulcers in diabetes mellitus (DM) are a common and serious complication that can lead to infection, amputation, and increased mortality. Early identification of patients at high risk is crucial in order to implement preventive measures at an early stage. The number of people with DM is increasing globally, from 540 million in 2021 to an estimated 780 million by 2045. Foot ulcers cause considerable suffering for the individual and entail substantial costs for the healthcare system.

Despite national guidelines recommending regular, structured foot examinations and risk classification to assess the risk of developing foot ulcers, current risk models do not take into account the complex interactions between risk factors and socioeconomic factors such as marital status, level of education, and place of residence.

Data-driven advances and artificial intelligence (AI) offer new opportunities to refine risk identification, but their use in predicting the risk of diabetic foot ulcers remains limited. The need for foot screening is considerable. In Sweden, there are approximately 600,000 patients with DM, and half of them live with an increased risk due to nerve damage in the feet. This means that, based on risk level, around 300,000 patients in Sweden may require preventive interventions, including medical foot care, customised footwear, and access to specialist care for those with foot ulcers. Improved preventive efforts are emphasised in the person-centred and integrated care pathway for people with diabetes at high risk of foot ulcers. However, accurate identification of foot ulcer risk is currently lacking.

Prevention leads not only to good quality of life for the individual but also to reduced healthcare costs. Estimates by Ragnarsson Tennvall show that a hard-to-heal ulcer costs approximately SEK 100,000 per year, while an amputation costs around SEK 300,000-500,000. Given a prevalence of foot ulcers of 5% among patients with diabetes, the annual cost of ulcer care amounts to SEK 3 billion. In addition, there are costs of approximately SEK 750 million for amputations, according to data from the quality register SwedAmp.

The aim of the study is to develop, test, and validate prediction models (statistical and AI-based) to identify patients with DM who are at risk of developing foot ulcers. The models will be based on retrospective electronic health record data from primary care in the Västra Götaland Region (VGR), as well as data from Statistics Sweden (SCB) concerning demographic factors such as marital status, level of education, occupation, and place of residence.

Methods The study has two methodological approaches: AI-based modelling and statistical modelling.

AI-based approach Machine learning models will be developed to predict patients at risk of developing diabetic foot ulcers. The models will be trained using cross-validation on a large dataset in which variables will be iteratively excluded. Conformal prediction will be used to quantify uncertainty in patient-level predictions. The resulting models will be analysed to identify the strongest predictors and will be compared with classical statistical modelling and findings from the literature.

Steps in AI modelling:

Data extraction: Electronic health record data from primary care in VGR, supplemented with sociodemographic data from SCB.

Data processing: Use of, among other variables, diagnostic codes (ICD-10), healthcare interventions (KVÅ codes), visit types, visit frequency, ECG parameters, and free-text data to construct predictors.

Model development: Prediction models will be developed and trained using cross-validation. Measures of uncertainty will be generated using conformal prediction.

Validation: A separate cohort will be used to test model performance (sensitivity, specificity, positive predictive value [PPV]).

Interpretation: The models will be reviewed for transparency and clinical interpretability in collaboration with patient representatives, clinicians, and researchers.

The results of the statistical and AI-based models will be compared with regard to their respective strengths and weaknesses.

Statistical modelling Two populations will be analysed: patients with diabetes without foot ulcers and patients with diabetes with foot ulcers. Co-variation and causal relationships between risk factors and foot ulcers will be identified. A model describing causal pathways leading to ulcer development will be developed, and its certainty and uncertainty will be analysed.
Detailed Description

In this register-based study, using data from Närhälsan's electronic health record system in the Västra Götaland Region (VGR) and linkage with data from Statistics Sweden (SCB), the research questions will be addressed through the development and validation of AI-based models. At a later stage of the process, the ability of the AI models to predict foot ulcers will be compared with that of statistical models.

From Asynja Whisp, Närhälsan's electronic health record system in VGR, data will be retrieved for all adult patients (18 years or older) with diagnoses (according to ICD-10) who either have a diabetes diagnosis (E10-E14) or have been prescribed any diabetes medication after the age of 18, covering the period from 2014 to 30 June 2025.

Based on, among other variables, diagnostic codes (ICD-10), procedure codes (KVÅ), visit types, visit frequency, ECG parameters, and free-text/clinical notes, predictors will be identified, such as neuropathy, impaired circulation, previous ulcers, antibiotic treatment, foot deformities, and skin status. The data will be validated and, if necessary, supplemented with additional parameters.

Methods to address the research questions

Machine learning-based models will be trained to predict the risk of developing foot ulcers. Cross-validation will be used to identify optimal hyperparameters for each model. In the first phase, the models' ability to discriminate between patients with diabetic foot ulcers and patients without foot ulcers will be evaluated. In the second phase, the models' ability to prospectively predict ulcer development will be assessed. Redundant variables will be excluded, and the models will be retrained in an iterative process to increase robustness.

The models will be combined with conformal prediction to integrate uncertainty estimation into the predictions and to identify patients for whom the model is unsuitable for prediction. Finally, the most predictive variables will be identified using Shapley values (SHAP).

Statistical models

Using electronic health record data from the Asynja Whisp care information system in VGR primary care, together with SCB data and scientific and empirical evidence, variables and categories that constitute potential risk factors for foot ulcers will be identified. A case-control design will be applied, in which the control group consists of people with diabetes who have not developed foot ulcers, compared with patients who have developed foot ulcers.

In the development of statistical prediction models, the workflow involves analysing populations, i.e. all patients with diabetes without foot ulcers compared with all patients with diabetes who have foot ulcers. This allows investigation of potential associations between the occurrence of foot ulcers in patients with diabetes and other factors. In collaboration with the medical profession, causal relationships underlying the occurrence of foot ulcers will be identified. A model will be developed that describes chains of causation leading to the occurrence of foot ulcers in patients with diabetes, and information will be provided on the degree of certainty of the model.

Based on the results of the models (both AI-generated and statistical), strengths and weaknesses of each approach will be compared. Validation of the developed models will be performed on an independent dataset to ensure that the results are generalisable and robust over time.

The validation strategy ensures that the model performs well on new patients and not only on the dataset from which it was developed. Outcome measures for validation include sensitivity (how well the model identifies those who truly have a high risk of foot ulcers), specificity (how well the model avoids false alarms), and positive predictive value (PPV). Furthermore, the model will be interpreted to ensure transparency and clinical interpretability. Development, testing, and validation will be conducted in collaboration with patient representatives, clinicians, and researchers.
Click to expand...

NewsBot · Feb 9, 2026

Lateral Plantar Artery Embolization For Plantar Fasciitis

Brief Summary

The goal of this clinical trial is to learn if lateral plantar artery embolization using Lipiodol can safely and effectively treat chronic heel pain due to plantar fasciitis in adults aged 25 to 80. The main questions it aims to answer are:

Does this procedure successfully reduce chronic heel pain as measured by the Visual Analog Scale (VAS) over 12 months?

How safe is the procedure, specifically regarding the frequency of serious medical problems or adverse events related to the device?

Participants will:

Undergo a minimally invasive procedure where a doctor uses a small tube (catheter) to inject a temporary blocking agent (LipioJoint) into specific blood vessels in the foot.

Receive a phone call one day after the procedure to check for early side effects.

Participate in four follow-up telehealth visits over the course of one year (at 1, 3, 6, and 12 months).

Complete pain intensity surveys (VAS) and report any changes in their use of other therapies or medications during these visits.
Click to expand...

Clinical Trials Updates

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

Discrepeances in foot related clinical trials between registration and publications

Sham or placebo foot orthotics for use in clinical trials

"sham" foot orthoses and clinical trials

Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals

What outcomes are important in clinical trials

Western clinical trials bad for traditional medicine

Clinical trials involving footwear & orthotics

Share This Page

Useful Searches