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

Temple University

Status: Unknown

Conditions: Diabetes; Equinus Contracture of the Ankle

Treatments: Device: Extra-corporeal pulsed-activated therapy or shockwave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02233140

21660

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Shockwave with manual manipulation

Experimental group

Description:

A shockwave (EPAT) therapy with two supervised manual manipulation per week

Treatment:

Device: Extra-corporeal pulsed-activated therapy or shockwave therapy

Manual manipulation

Active Comparator group

Description:

A Placebo (no) shockwave with two supervised manual manipulations per week

Treatment:

Device: Extra-corporeal pulsed-activated therapy or shockwave therapy