Evaluation of Integra® Artificial Dermis for the Treatment of Leg Ulcers

Completed

• Conditions: Lower Limb Ulcer

• Registration Number: NCT01285973
• Lead Sponsor: Integra LifeSciences Services

Brief Summary

The aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound.

This is a multi-centre study on 60 patients who have a lower limb ulcer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-28
• Study Start: 2011-04
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patient with a lower limb ulcer, regardless of origin (arterial, venous or mixed, diabetic foot ulcer) present for more than 6 months or large in size (> 10 cm²)
• patients in whom the surgeon has recommended that an Integra® matrix be implanted (even if the patient is not taking part in the study) before the dermo-epidermal graft to obtain a richly vascularised neodermis.
• not eligible for skin flap surgery,
• the patient or patient's representative has agreed to sign the information letter before any investigation required by the research.

Exclusion Criteria

• circumferential wound,
• wound infection
• immunosuppressed patient,
• known allergy to bovine collagen, bovine glycosaminoglycans or silicone,
• patients under legal guardianship,
• pregnant women
• patients whose health would compromise follow-up for at least 18 months,
• patients whose mental health would compromise completion of the self-evaluation questionnaires.
• wound located in an area not visible by the patient (as no self-assessment would be possible).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a greater than 50% reduction in wound surface area during the 18 months after grafting.	18 months

Secondary Outcome Measures

Name	Time	Method
Complete wound healing (reduction in wound surface area >90%)	3, 6, 12, 18 months
Functional complications of healing at 3, 6, 12 and 18 months	3, 6, 12 and 18 months
Pain	3, 6, 12, 18 months
Quality of life	3, 6, 12, 18 months
Transcutnaeous oxygen pressure (TcPO2)	6, 12 and 18 months

Trial Locations

Locations (3)

Bordeaux University Hospital,; 🇫🇷 Bordeaux, France

Policlinico Universitario "G. Martino"; 🇮🇹 Messina, Italy

Aristotle University of Thessaloniki - Papageorgiou General Hospital; 🇬🇷 Thessaloniki, Greece