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OpenTrials
Completed

NCT Number: NCT01285973

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

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bordeaux University Hospital,, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

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

    Time frame: 18 months

Secondary outcomes

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

    Time frame: 3, 6, 12 and 18 months

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

    Time frame: 3, 6, 12, 18 months

  3. Pain

    Time frame: 3, 6, 12, 18 months

  4. Quality of life

    Time frame: 3, 6, 12, 18 months

  5. Transcutnaeous oxygen pressure (TcPO2)

    Time frame: 6, 12 and 18 months

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Services

Industry

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 28, 2011
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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