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
- ulcera cruris venosa, ulcera cruris arterio(lo)scleroticum and ulcers of mixed origin
- Registration Number
- NL-OMON27551
- Lead Sponsor
- WO-Biopartner First Stage Grant
- Brief Summary
/A
- Detailed Description
Not available
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;
Exclusion Criteria
1. Diabetic foot ulcers;
2. Serious co-morbidity which decreases the life expectancy to less than 2 years;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness of treatment of therapy resistent, chronic ulcera cruris (>5 months open; >2 months with no sign of healing), with Tiscover.
- Secondary Outcome Measures
Name Time Method 1. Determine whether hospitalization and wound bed preparation have a beneficial effect;<br /><br>2. Evaluate unforeseen toxicity due to Tiscover treatment; <br /><br>3. Evaluate the durability of treatment with Tiscover;<br /><br>4. Determine whether out-patient treatment with Tiscover is possible;<br /><br>5. Compare the costs of Tiscover treatment with present costs for caring/treatment of inert ulcera cruris without Tiscover.