Chronic Diabetic Foot Ulcers
Conditions
Keywords
Foot Ulcers, Extracorporeal Shockwave, Chronic wound
Brief 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).
Interventions
PROCEDUREExtracorporeal Shock Wave
Sponsors
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 and older * Diabetes Type I or II * Chronic ulcer on the foot * Ulcer present for at least 6 weeks * Wagner Grade 1 or 2
Exclusion criteria
* Chronic rest pain * Critical ischemia * Gangrene * Ankle-Arm-Index \< 0,5 * Critical ischemia treated within 6 weeks before possible enrollment * Ulcer of Grade 3 or worse according to the Wagner Classification * Osteomyelitis * Affection of toes * Necessity of surgical intervention * Malalignment of the foot sustaining the ulcer * Treatment of Ulcer with Prostaglandins or vasodilatators within the last 2 weeks * Current therapy with corticoids * Infection with HIV; Hepatitis * Suppression of immune system (due to illness or medication) * Medication with Vitamin-K-Antagonists * Known hemophilia * Sever Hypalbuminemia \< 2 g/dl * Severe anemia * Ulcer other than of diabetic origin * Pregnant or breast-feeding women * Known coagulopathies * Implants such as artificial heart valves, joint replacement, bone replacement, osteosynthesis material * Patients participating on other studies * Chemotherapy within the last 60 days * Mentally disabled patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed