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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01285973
Recruitment Status : Completed
First Posted : January 28, 2011
Last Update Posted : August 13, 2015
Information provided by (Responsible Party):
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.

Condition or disease
Lower Limb Ulcer

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : April 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01285973

Bordeaux University Hospital,
Bordeaux, France
Aristotle University of Thessaloniki - Papageorgiou General Hospital
Thessaloniki, Greece
Policlinico Universitario "G. Martino"
Messina, Italy
Sponsors and Collaborators
Integra LifeSciences Services

Responsible Party: Integra LifeSciences Services Identifier: NCT01285973     History of Changes
Other Study ID Numbers: RECON-EMEA-10
First Posted: January 28, 2011    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015