An interventional study of Extracorporeal Shock Wave and Extracorporeal Shock Wave in Chronic Diabetic Foot Ulcers, sponsored by Technical University of Munich. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-19.
Sponsored by Technical University of Munich · Not applicable, Interventional, and Treatment
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).
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
Browse Diabetic Foot studies →Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Extracorporeal Shock Wave
Procedure: Extracorporeal Shock Wave
Procedure: Extracorporeal Shock Wave
Procedure: Extracorporeal Shock Wave
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
This study is withdrawn, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Technical University of Munich