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

This study is currently recruiting participants.
Verified October 2012 by Integra LifeSciences Services
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Services
ClinicalTrials.gov Identifier:
NCT01285973
First received: January 27, 2011
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

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
Lower Limb Ulcer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Integra LifeSciences Services:

Primary Outcome Measures:
  • Proportion of patients with a greater than 50% reduction in wound surface area during the 18 months after grafting. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional complications of healing at 3, 6, 12 and 18 months [ Time Frame: 3, 6, 12 and 18 months ] [ Designated as safety issue: Yes ]
  • Complete wound healing (reduction in wound surface area >90%) [ Time Frame: 3, 6, 12, 18 months ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 3, 6, 12, 18 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 3, 6, 12, 18 months ] [ Designated as safety issue: No ]
  • Transcutnaeous oxygen pressure (TcPO2) [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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.

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285973

Contacts
Contact: Marilyne BLANC marilyne.blanc@integralife.com

Locations
France
Bordeaux University Hospital, Recruiting
Bordeaux, France
Principal Investigator: Vincent CASOLI, Pr            
Greece
Aristotle University of Thessaloniki - Papageorgiou General Hospital Recruiting
Thessaloniki, Greece
Principal Investigator: Efterpi DEMIRI, Dr            
Italy
Policlinico Universitario "G. Martino" Recruiting
Messina, Italy
Principal Investigator: Gabriele DELIA, Dr            
Sponsors and Collaborators
Integra LifeSciences Services
  More Information

No publications provided

Responsible Party: Integra LifeSciences Services
ClinicalTrials.gov Identifier: NCT01285973     History of Changes
Other Study ID Numbers: RECON-EMEA-10
Study First Received: January 27, 2011
Last Updated: October 9, 2012
Health Authority: France: Institutional Ethical Committee
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: French Data Protection Authority

Additional relevant MeSH terms:
Ulcer
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013