Status:
WITHDRAWN
Shockwave Treatment of Diabetic Foot Ulcer: Step I
Lead Sponsor:
Technical University of Munich
Conditions:
Chronic Diabetic Foot Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00954343
Start Date
August 1 2009
Last Update
March 19 2013
Active Locations (1)
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1
Klinik für Orthopädie und Unfallchirurgie, Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675