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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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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a greater than 50% reduction in wound surface area during the 18 months after grafting. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional complications of healing at 3, 6, 12 and 18 months | 3, 6, 12 and 18 months | |
| Complete wound healing (reduction in wound surface area >90%) | 3, 6, 12, 18 months | |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux University Hospital, | Bordeaux | France | ||||
| Aristotle University of Thessaloniki - Papageorgiou General Hospital |
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| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Pain |
| 3, 6, 12, 18 months |
| Quality of life | 3, 6, 12, 18 months |
| Transcutnaeous oxygen pressure (TcPO2) | 6, 12 and 18 months |
| Thessaloniki |
| Greece |
| Policlinico Universitario "G. Martino" | Messina | Italy |