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

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

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.