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 enrollmentJanuary 27, 2006

Overview

No summary available.

Registry

who.int

Start Date

January 27, 2006

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sponsor

VU University Medical Centre (VUMC) (Netherlands)

•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

•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