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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Lower Limb Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No