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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Services
ClinicalTrials.gov Identifier:
NCT01285973
First received: January 27, 2011
Last updated: December 31, 2013
Last verified: December 2013
  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:


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: June 2014
Estimated Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285973

Locations
France
Bordeaux University Hospital,
Bordeaux, France
Greece
Aristotle University of Thessaloniki - Papageorgiou General Hospital
Thessaloniki, Greece
Italy
Policlinico Universitario "G. Martino"
Messina, Italy
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: December 31, 2013
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 August 25, 2014