Shockwave Treatment of Diabetic Foot Ulcer: Step I (STUF)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Shockwave Treatment of Diabetic Foot Ulcer. A Prospective, Controlled, Randomized Trial. Step 1|
- Percentage decrease of ulcer size twelve weeks after treatment begin (i.e. first shock wave treatment) compared to the baseline (ulcer size at first treatment)
- Rate of completely healed ulcer 6, 9 and 12 weeks after first treatment
- Percentage decrease of ulcer size 6 and 9 weeks after first treatment
- Tissue oxygen concentration after shock wave treatment
|Study Start Date:||August 2009|
|Experimental: Group I||Procedure: Extracorporeal Shock Wave|
|Experimental: Group II||Procedure: Extracorporeal Shock Wave|
|Experimental: Group III||Procedure: Extracorporeal Shock Wave|
|Experimental: Group IV||Procedure: Extracorporeal Shock Wave|
|No Intervention: Group V|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954343
|Klinik für Orthopädie und Unfallchirurgie, Klinikum rechts der Isar|
|Munic, Bavaria, Germany, 81675|
|Principal Investigator:||Hans Gollwitzer, PD Dr., CCRP||Klinik für Orthopädie und Unfallchirurgie Klinikum rechts der Isar|