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

Study Overview
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Brief Summary
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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.

Official Title
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Do Physical Manipulation Exercises With EPAT Improve Ankle Dorsiflexion and Reduce Dynamic Plantar Forefoot Pressure in Diabetic Subjects With Equinus?: A Pilot RCT

Conditions
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Diabetes, Equinus Contracture of the Ankle

Intervention / Treatment
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* Device: Extra-corporeal pulsed-activated therapy or shockwave therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shockwave with manual manipulation<br>A shockwave (EPAT) therapy with two supervised manual manipulation per week | Device: Extra-corporeal pulsed-activated therapy or shockwave therapy<br> <br> * Other names: D-Actor® 200;|
| Active Comparator: Manual manipulation<br>A Placebo (no) shockwave with two supervised manual manipulations per week | Device: Extra-corporeal pulsed-activated therapy or shockwave therapy<br> <br> * Other names: D-Actor® 200;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks |  | at baseline visit and at 4 weeks | 
| Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks. |  | at baseline visit and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months. |  | at 1 month and at 3 months | 
| Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from 1 month to 3 months. |  | at 1 month and at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Ankle equinus, ankle dorsiflexion, dynamic plantar pressure, shockwave therapy