2360358
Last Update Posted: 2016-01-07
Recruiting has ended
All Genders accepted | 18 Years + |
8 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Autologous Skin Substitute for Chronic Leg/Foot Ulcers.
A prospective, multicenter, randomised controlled phase II study in which patients with therapy resistant (arterio-) venous leg/foot ulcers are treated with Tiscover® (test group) or with AS210 (control group) to determine the safety and relative efficacy of both products.
Multicenter, randomised clinical trial in out patient in which patients with chronic (arterio-) venous leg/foot ulcers are treated with an autologous cultured human living skin substitute (Tiscover®: test group) or with Acellular donor dermis (AS210: control group). During a pre-inclusion evaluation period of 4 weeks (non healing) chronicity of ulcer is ensured (ulcer size change of < 30%). To determine ulcer type ABI, Doppler and CEAP is performed.
The test group will receive 2 applications of Tiscover®. Week 0: wound activating pre-treatment, application of at least one quarter of the wound surface. Week 1: removal of patches, application of patches on total wound surface.
The control group (16 patients) will follow the same application protocol.
Eligibility
Relevant conditions:
Varicose Ulcer
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
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Contact Information
Overall Contact
No valid contacts available
Data sourced from ClinicalTrials.gov