Recruiting

Manual Manipulation

Sponsor:

Temple University

Code:

NCT02233140

Conditions

Diabetes

Equinus Contracture of the Ankle

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Extra-corporeal pulsed-activated therapy or shockwave therapy

Study Details

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.

Conditions

Diabetes

Equinus Contracture of the Ankle

Study ID

NCT02233140

Start date

Oct, 2014

Status verified date

Aug, 2015

Completion date

Oct, 2017

Anticipated

Primary completion date

Oct, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men and women between the ages of 21 to 65, inclusive
  • Diabetes, either type 1 or 2
  • Ankle equinus (< 0ยบ 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

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Shockwave with manual manipulation

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

active comparator: Manual manipulation

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

Interventions

Extra-corporeal pulsed-activated therapy or shockwave therapy

Primary outcome measure

  • Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks [ Time Frame: at baseline visit and at 4 weeks ]
  • Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks. [ Time Frame: at baseline visit and 4 weeks ]

Central Contacts and Locations

Central contacts

Jinsup Song, D.P.M., Ph.D.

215-625-5369jsong@temple.edu

Locations

Gait Study Center at the Temple University School of Podiatric Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Jinsup Song, D.P.M., Ph.D.

215-625-5369jsong@temple.edu

Principal Investigator:

Jinsup Song, D.P.M., Ph.D.

More Information

Sponsor

Temple University

Last update posted

Aug 27, 2015

Last verified

Aug, 2015

Keywords

  • Diabetes
  • Ankle equinus
  • ankle dorsiflexion
  • dynamic plantar pressure
  • shockwave therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Temple University on 2015-08-27.