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Shockwave Treatment of Diabetic Foot Ulcer: Step I

NCT00954343 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-03-19

No results posted yet for this study

Summary

Extracorporeal Shock Wave treatment is a well established treatment in orthopedics. Considerable success has been reported after treatment of various soft tissue pathologies (Tendinitis, heel spur etc). In recent years, encouraging results have been reported concerning the effect of the shock-wave on chronic wounds. It has been reported that healing time can be considerably shortened if shock-waves are applied to the wound in addition to conventional wound treatment. Yet, randomized, controlled, prospective trials are missing.

In this study, the effect of shock-waves on diabetic foot ulcer shall be assessed.

The study is composed of 5 groups of which 4 groups receive shock wave treatments (each with a different protocol). One group serves as an untreated control group. All groups get standardized wound treatment and wound dressing.

That shock-wave application protocol that shows the best results (rate of completely healed ulcer, most decrease of ulcer size) shall be tested in a further, sufficiently dimensioned, two-armed, randomized controlled trial (RCT).

Conditions

  • Chronic Diabetic Foot Ulcers

Interventions

PROCEDURE

Extracorporeal Shock Wave

PROCEDURE

Extracorporeal Shock Wave

PROCEDURE

Extracorporeal Shock Wave

PROCEDURE

Extracorporeal Shock Wave

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Hans Gollwitzer, PD Dr., CCRP · Klinik für Orthopädie und Unfallchirurgie Klinikum rechts der Isar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31

Countries

  • Germany

Study Locations

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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 NCT00954343 on ClinicalTrials.gov