Treatment of Cutaneous Ulcers With a Novel Biological Dressing

Laval University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Venous Ulcers

Treatments: Device: self assembled skin substitute (SASS)

Study type: Interventional

Funder types: Other

Identifiers

NCT00207818

LOEX 005

29478 Health Canada

Details and patient eligibility

About

The aim of the study is to evaluate the effect of a biological dressing on the healing process of venous ulcers. The dressing is a reconstructed skin substitute made with the patients own cells.

Full description

The hypothesis of this trial is that the cutaneous model SASS, a dermal epidermal skin substitute, created by the LOEX could be as high-performant, or even better, than the one's already existent in North America for the wound care. We anticipate showing on 6 patients that ulcer that did not close with conventional treatment, will heal or at least improve with this treatment.

Enrollment: 6 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men or women from 18 to 85 years old
2. Have a venous ulcer or a mixed ulcer

Exclusion criteria

Diabetes Mental deficiency Hepatitis holder (A-B-C) HIV positive Pregnancy or lactation Corticosteroids therapy Radiotherapy Chemotherapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)