Lower Limb Ulcer Clinical Trial
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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). |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Bordeaux University Hospital, | Bordeaux | |
| Greece | Aristotle University of Thessaloniki - Papageorgiou General Hospital | Thessaloniki | |
| Italy | Policlinico Universitario "G. Martino" | Messina |
| Lead Sponsor | Collaborator |
|---|---|
| Integra LifeSciences Services |
France, Greece, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients with a greater than 50% reduction in wound surface area during the 18 months after grafting. | 18 months | No | |
| Secondary | Functional complications of healing at 3, 6, 12 and 18 months | 3, 6, 12 and 18 months | Yes | |
| Secondary | Complete wound healing (reduction in wound surface area >90%) | 3, 6, 12, 18 months | No | |
| Secondary | Pain | 3, 6, 12, 18 months | No | |
| Secondary | Quality of life | 3, 6, 12, 18 months | No | |
| Secondary | Transcutnaeous oxygen pressure (TcPO2) | 6, 12 and 18 months | No |