Effectiveness of Manual Manipulation With EPAT on Ankle Dorsiflexion and Dynamic Plantar Pressure (NCT02233140) | Clinical Trial Compass
UnknownNot Applicable
Effectiveness of Manual Manipulation With EPAT on Ankle Dorsiflexion and Dynamic Plantar Pressure
United States48 participantsStarted 2014-10
Plain-language summary
Diabetic foot complications are a common and costly problem. Excessive plantar pressures due to foot deformities and/or limited ankle dorsiflexion, especially in the presence of peripheral neuropathy, can predispose subjects with diabetes for diabetic foot ulcers. Achilles tendon lengthening surgery has shown to delay or prevent recurrence of diabetic foot ulcers.
Studies have shown that Shockwave Therapy (EPAT - Extracorporeal Pulse Activation Technology) was effective in treating subjects with chronic heel pain and Achilles tendonitis with no serious side effects. EPAT, therefore, may allow diabetic patients with ankle equinus to perform more effective stretching exercises and may prevent recurrence of diabetic foot ulcers.
The purposed of this RCT is to compare effectiveness of manual manipulation with EPAT versus manual manipulation alone on ankle dorsiflexion and dynamic plantar pressure in at-risk subjects with a history of diabetic foot ulcer.
Who can participate
Age range
21 Years – 65 Years
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:
* Men and women between the ages of 21 to 65, inclusive
* Diabetes, either type 1 or 2
* Ankle equinus (\< 0º passive ankle dorsiflexion with knee extended)
* Forefoot plantar hyperkeratosis (callus)
* Able to walk independently without the use of walking aids (cane, crutches, or walker)
* Able to understand the information in the informed consent form and willing and able to comply with study-related procedures
Exclusion Criteria:
* Previous history of ankle-foot surgery or amputation
* no active lower extremity skin ulcers
* Peripheral vascular disease (non-palpable pedal pulses or ankle brachial index \<0.8)
* Not willing or able to make required visits
* Nursing or pregnant
* Not willing or able to follow procedures specified by protocol and/or instructions of the study personnel, including discontinuation of icing, NSAIDs and natural anti-inflammatory agents (such as Arnica)
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.
What they're measuring
1
Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks
Timeframe: at baseline visit and at 4 weeks
2
Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks.