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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

January 27, 2011
October 9, 2012
April 2011
September 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01285973 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Evaluation of Integra® Artificial Dermis for the Treatment of Leg Ulcers
Not Provided

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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.
Lower Limb Ulcer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
September 2013
September 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years to 90 Years
No
Contact: Marilyne BLANC marilyne.blanc@integralife.com
France,   Greece,   Italy
 
NCT01285973
RECON-EMEA-10
No
Integra LifeSciences Services
Integra LifeSciences Services
Not Provided
Not Provided
Integra LifeSciences Services
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP