Shockwave Treatment of Diabetic Foot Ulcer: Step I — STUF  

Chronic Diabetic Foot Ulcers Clinical Trial

Official title: Shockwave Treatment of Diabetic Foot Ulcer. A Prospective, Controlled, Randomized Trial. Step 1

Status Withdrawn

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Diabetic Foot Ulcers
• Diabetic Foot
• Foot Ulcer
• Ulcer

• NCT number: NCT00954343
• Study type: Interventional
• Source: Technische Universität München
• Status: Withdrawn
• Phase: N/A
• Start date: August 2009