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

NCT02233140 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-08-27

No results posted yet for this study

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.

Conditions

  • Diabetes
  • Equinus Contracture of the Ankle

Interventions

DEVICE

Extra-corporeal pulsed-activated therapy or shockwave therapy

Sponsors & Collaborators

  • Temple University

    lead OTHER

Principal Investigators

  • Jinsup Song, DPM, PhD · Temple University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-10-31
Completion
2017-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02233140 on ClinicalTrials.gov