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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02233140
• Other study ID #: 21660
• Status: Recruiting
• Phase: N/A
• First received: August 28, 2014
• Last updated: August 26, 2015
• Start date: October 2014
• Est. completion date: October 2017

Study information

• Verified date: August 2015
• Source: Temple University
• Contact: Jinsup Song, D.P.M., Ph.D.
• Phone: 215-625-5369
• Email: jsong[@]temple.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clubfoot
• Contracture
• Diabetes
• Equinus Contracture of the Ankle
• Equinus Deformity

Intervention

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

Locations

Country	Name	City	State
United States	Gait Study Center at the Temple University School of Podiatric Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks		at baseline visit and at 4 weeks	No
Primary	Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks.		at baseline visit and 4 weeks	No
Secondary	Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months.		at 1 month and at 3 months	No
Secondary	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	No