ISRCTN86386707CompletedNot Applicable
An open, randomized, (out-patient) clinical study into the effectiveness, durability and cost efficiency of Tiscover® (cultured, autologous skin) for chronic leg wounds (ulcera cruris)
VU University Medical Centre (VUMC) (Netherlands)0 sites100 target enrollmentStarted: January 27, 2006Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Ulcus cruris venosum, ulcus cruris arterio(lo)scleroticum and ulcers of mixed origin
- •2. Non-vital ulcers which exist for at least 5 months and which do not respond to adequate compression therapy and local wound treatment
- •3. Ulcers between 5 and 100 square cm
- •4. Signed informed consent
- •5. Ankle/arm index >0.7
Exclusion Criteria
- •1. Diabetic foot ulcers
- •2. Serious co-morbidity which decreases the life expectancy to less than 2 years
- •3. Use of high doses of corticosteroids and/or cytostatic drugs (>20 mg/day)
- •4. Diagnosed Penicillin allergy
- •5. Serious infection of the ulcer bed at time t = 0
- •6. Disturbances of psychiatric nature where the following of medical advice becomes a problem
- •7. Declining clinical treatment and/or follow up visits
Investigators
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