Pivotal Study to Evaluate the Efficacy and Safety of Dermal-Living Skin Replacement (Dermal-LSR) in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.
• Has signed a written informed consent prior to the first study intervention
• Is at least 18 and <85 years of age
• Has one or more diabetic foot ulcers on the target limb, with only one marked for the study (target ulcer). It must have the following characteristics:Plantar; Grade 2 per Curative Health Services Classification; Non-infected; Neuropathic; Non-malignant; At least 1.0-25cm^2 post-debridement; Present for at least 6 weeks
• Has Type I or II Diabetes Mellitus with an HBA1c between 6-10%
• Has a maximum fasting blood glucose level of 13.8 mmol/L
• An ankle-brachial systolic pressure index between 0.7 and 1.3
• If female and of childbearing potential has a negative serum pregnancy test and is neither breastfeeding or intending to become pregnant during the study
• Able and willing to attend the scheduled visits and comply with study procedures.