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

NCT01285973 | Completed

• 1 other identifier: RECON-EMEA-10
• Study Type: observational
• Target: 30
• Locations: 3 countries
• Sites: 3

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.

Conditions

Lower Limb Ulcer

Outcome Measures

Primary Outcomes (1)

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

  18 months

Secondary Outcomes (5)

• Functional complications of healing at 3, 6, 12 and 18 months

  3, 6, 12 and 18 months

• Complete wound healing (reduction in wound surface area >90%)

  3, 6, 12, 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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will be patients with "difficult" lower limb ulcers, whose wounds have not responded to directed healing for more than 6 months or who have a wound \> 10 cm².

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Integra LifeSciences Services: lead

Study Sites (3)

Bordeaux University Hospital,

Bordeaux, France

Location

Aristotle University of Thessaloniki - Papageorgiou General Hospital

Thessaloniki, Greece

Location

Policlinico Universitario "G. Martino"

Messina, Italy

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: January 28, 2011
• Study Start: April 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

IT (1); FR (1); GR (1)