NCT02360358

Autologous Skin Substitute for Chronic Leg/Foot Ulcers.

A Phase II Randomized Multicenter Study on Efficacy and Safety of Cultured Autologous Skin (Tiscover®) and Acellular Dermal Matrix (AS210) in Chronic (Arterio-)Venous Ulcers

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Chantal Blok · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Varicose Ulcer

Interventions

Type	Name	Description
DRUG	Tiscover	two step procedure, week 0 and week1. Dosage depends on wound size.
OTHER	AS210	two step procedure, week 0 and week1. Dosage depends on wound size.

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-02-10
• Last updated: 2016-01-07

Locations

5 sites across 1 country: Netherlands