NL-OMON56830
Not yet recruiting
Not Applicable
Treatment of chronic diabetic foot ulcers with Extracorporeal Shock Wave Therapy (ESWT) - a double-blind randomized controlled trial - Shock Wave for diabetic foot ulcers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- chronic diabetic foot ulcer
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 54
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or older
- •Diabetes mellitus type I or 2
- •Uni\- or bilateral chronic foot ulcers which have not healed for 6 weeks
- •Grade 1A or 2A ulcer according to the Texas Diabetic Foot Wound
- •Classification System
- •Diameter of the ulcer \> 0\.5 cm and \< 5 cm on the plantar side of the foot
- •Ankle\-brachial index \> 0\.7
- •Toe systolic pressure \> 50 mmHg
- •Participants are mentally competent to understand and sign a Dutch informed
- •consent form themselves
Exclusion Criteria
- •History of neoplasia or malignancy near the chronic diabetic foot ulcer
- •Pregnancy
- •Skeletal immaturity which has an influence on the ability to walk
- •Sign of acute local infection demanding the use of systemic antibiotics or
- •the need for amputation
- •Osteomyelitis or gangrene in the affected extremity
- •Severe anemia (Hb \< 7,0g/dl)
- •Ankle brachial index \< 0\.7
- •Toe systolic pressure \< 50 mmHg
- •Any history with ESWT
Outcomes
Primary Outcomes
Not specified
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