Effectiveness of Manual Manipulation With EPAT on Ankle Dorsiflexion and Dynamic Plantar Pressure

Status unconfirmed · Not applicable

Conditions studied: Diabetes, Equinus Contracture of the Ankle

In brief

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.

Key facts

Study ID

NCT02233140

Run by

Temple University

People needed

48

Starts

2014-10-01

Expected to finish

2017-10-01

Last updated by the study team

2015-08-27

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Gait Study Center at the Temple University School of Podiatric Medicine — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.