Treatment of Cutaneous Ulcers With a Novel Biological Dressing

Phase 2CompletedNCT00207818

CHU de Quebec-Universite Laval6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Venous Ulcers

Interventions

self assembled skin substitute (SASS)DEVICE

Wound care with self assembled skin substitute (SASS)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre hospitalier affilie universitaire de Quebec

Québec, Quebec, Canada

Outcomes

Primary Outcomes

wound closure

Secondary Outcomes

% of healing at 6 months of treatment

Data from ClinicalTrials.gov

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