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)

Completed

• Conditions: lcera cruris venosa, ulcera cruris arterio(lo)scleroticum, ulcers of mixed origin; Varicose veins of lower extremities; Circulatory System

• Registration Number: ISRCTN86386707
• Lead Sponsor: VU University Medical Centre (VUMC) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified