The Role of Extrinsic Foot Muscles Chances in Determining the Risk of Diabetic Foot Ulcer (NCT06736210) | Clinical Trial Compass
CompletedNot Applicable
The Role of Extrinsic Foot Muscles Chances in Determining the Risk of Diabetic Foot Ulcer
Turkey (Türkiye)30 participantsStarted 2024-11-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Patients with Diabetes:
* Willingness to participate in the study
* Absence of current or past diabetic foot ulcers
* Classification within the 0 or 1 categories of the IWGDF classification system
Inclusion Criteria for Sedentary Healthy Participants:
* Willingness to participate in the study
* Not engaging in active sports activities
* Absence of current or past foot ulcers
Exclusion Criteria for all group:
* Presence of orthopedic, musculoskeletal, vestibular, visual, or neurological problems affecting mobility (other than DPN)
* History of prior orthopedic surgical intervention in the lower extremity
* Dementia or inability to provide consistent information
* Presence of major vascular complications (venous or arterial ulcers)
* Diagnosis of PAH (Peripheral Arterial Hypertension)
* Presence of plantar ulcers during or prior to the assessment
* Inability to walk independently without pain or assistive devices
* Illiteracy
* Presence of any foot deformity
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.