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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-10-31

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.

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Detailed Description

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Conditions

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Diabetes Equinus Contracture of the Ankle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Shockwave with manual manipulation

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

Group Type EXPERIMENTAL

Extra-corporeal pulsed-activated therapy or shockwave therapy

Intervention Type DEVICE

Manual manipulation

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

Group Type ACTIVE_COMPARATOR

Extra-corporeal pulsed-activated therapy or shockwave therapy

Intervention Type DEVICE

Interventions

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Extra-corporeal pulsed-activated therapy or shockwave therapy

Intervention Type DEVICE

Other Intervention Names

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D-Actor® 200

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)

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No