Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers

Inclusion criteria

• Patient is at least 18 years old
• Patient is willing and capable of complying with all protocol requirements
• Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to or at the beginning of the run-in period
• Patient has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association)
• Ulcer must be located at least in part on the foot or ankle
• Ulcer must be present for a minimum of 28 days prior to randomization and initial application of study product
• Wound size must be < 30cm2 on the day of randomization and initial application of the study product, after initial debridement
• Patient has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization:

• Dorsum transcutaneous oxygen test (TcPO2) of study leg with results ≥40mmHg, OR
• Ankle-Brachial Index (ABI) of study leg with results of ≥ 0.7
• Toe-Brachial Index (TBI) of study extremity with results of > 50 mmHg

Exclusion criteria

• Patient has been previously enrolled into this study, or is currently participating in another drug or device study that has not reached its primary endpoint
• Patient is pregnant, breast feeding or planning to become pregnant
• Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
• Patient has a life expectancy less than six months as assessed by the investigator
• Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period
• Patient has an additional wound within 3 cm of the study wound
• Hgb A1c > 12% within 3 months prior to randomization in patients with a known history of diabetes
• Patient not in reasonable metabolic control in the judgment of the investigator
• Patient with a known history of poor compliance with medical treatments
• Patient currently undergoing cancer treatment
• Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
• Patient is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the run-in period or up to 30 days before the run-in period. Chronic oral steroid use is not excluded if dose is < 10 mg per day for prednisone.
• Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgment of the investigator
• Osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence
• Patient unwilling to or unable to safely utilize appropriate offloading device to unweight wound
• Study ulcer spontaneously closes during the 2-week run in period