Shockwave Treatment of Diabetic Foot Ulcer: Step I
STUF
1 other identifier
interventional
N/A
1 country
1
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).
Trial Health
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedFirst Posted
Study publicly available on registry
August 7, 2009
CompletedMarch 19, 2013
March 1, 2013
July 31, 2009
March 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
Secondary Outcomes (3)
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 Arms (5)
Group I
EXPERIMENTALGroup II
EXPERIMENTALGroup III
EXPERIMENTALGroup IV
EXPERIMENTALGroup V
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinik für Orthopädie und Unfallchirurgie, Klinikum rechts der Isar
Munich, Bavaria, 81675, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hans Gollwitzer, PD Dr., CCRP
Klinik für Orthopädie und Unfallchirurgie Klinikum rechts der Isar
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 31, 2009
First Posted
August 7, 2009
Study Start
August 1, 2009
Last Updated
March 19, 2013
Record last verified: 2013-03