A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers

Exclusion Criteria

• •1. Subject has major uncontrolled medical disorder such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
• •2. Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound.
• •3. The Subject has other concurrent conditions that, in the opinion of the Investigator, may compromise subject safety.
• •4. Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
• •5. Subject is pregnant or breast feeding.
• •6. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
• •7. Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the l 30 days preceding the first treatment visit.
• •8. Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of treatment visit 1.
• •9. Known HbA1C \>12%.
• •10. Mini-nutritional assessment Malnutrition Indication score \<17.