Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers

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.

The study is a pivotal, prospective, randomized, controlled, open-label, multi-center study that will evaluate the effectiveness and safety of topically applied Dermal-LSR in chronic DFUs.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Known or suspected disease of the immune system
• Active or untreated malignancy or active, uncontrolled connective tissue disease
• Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment
• Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
• Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to enrollment
• Active febrile illness
• AST, ALT, ALP >3x the normal upper limit
• Serum Creatinine >2x the normal upper limit
• Osteomyelitis
• Active Charcot
• Use of any topical treatments other than SOC (standard of care)at the time of enrollment
• Enrollment in any investigational clinical trial within 30 days of the screening visit
• Known or suspected hypersensitivity to any study product components
• Recent or current history of alcohol or drug abuse
• Any condition, which in the opinion of the Investigator, would interfere with the evaluation of the study product or poses a health risk to the subject
• All site personnel directly affiliated with this study and their immediate families