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

Not Applicable

• Conditions: Diabetes; Equinus Contracture of the Ankle
• Interventions: Device: Extra-corporeal pulsed-activated therapy or shockwave therapy

• Registration Number: NCT02233140
• Lead Sponsor: Temple University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-28
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-08
• Study Start: 2014-10
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-26
• Last Update Posted: 2015-08-27
• Primary Completion: 2016-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shockwave with manual manipulation	Extra-corporeal pulsed-activated therapy or shockwave therapy	A shockwave (EPAT) therapy with two supervised manual manipulation per week
Manual manipulation	Extra-corporeal pulsed-activated therapy or shockwave therapy	A Placebo (no) shockwave with two supervised manual manipulations per week

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Gait Study Center at the Temple University School of Podiatric Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States