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

Temple University48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Equinus Contracture of the Ankle

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks

Time frame: at baseline visit and at 4 weeks

Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks.

Time frame: at baseline visit and 4 weeks

Secondary Outcomes

Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months.

Time frame: 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.