Evaluating The Efficacy Of A Keratin Graft In Treating Non-Healing Diabetic Foot Ulcers

Inclusion Criteria:

• Diagnosis of type 1 or 2 diabetes mellitus
• Target diabetic foot ulcer with a minimum surface area of 1.0 cm^2 and a maximumsurface area of 20.0 cm^2 measured post-debridement with photographic planimetry.
• Target ulcer must have been present for a minimum of 4 weeks and maximum of 52 weeksof standard of care prior to initial screening
• Target ulcer must be located on the foot with at least 50% of its area below themalleolus
• Target ulcer must be full thickness on the foot or ankle that does not probe to bone
• Adequate circulation in the affected foot documented within 3 months of initialscreening visit, as determined by one of the following: transcutaneous oximetrymeasurement (TCOM) greater or equal to 30 mmHg, ankle-brachial index (ABI) between 0.7and 1.3, biphasic pulse volume recording (PVR), toe-brachial index (TBI) greater than 0.6, or arterial Doppler ultrasound evaluating for biphasic dorsalis pedis andposterior tibial vessels at the ankle level
• If subject has two or more ulcers, they must be separated by at least 2 cm. Thelargest ulcer satisfying the inclusion and exclusion criteria will be designated asthe target ulcer
• Target ulcers on the plantar aspect of the foot must be offloaded for at least 14 daysprior to randomization
• Subject must consent to using the prescribed off-loading method for the duration ofthe study
• Subject must agree to attend weekly study visits required by the protocol
• Subject must be willing and able to participate in the informed consent process

Exclusion Criteria:

• Subjects known to have a life expectancy of < 6 months
• Infection of the target ulcer or cellulitis in the surrounding skin
• Presence of osteomyelitis or exposed bone, or wounds that probe to bone or jointcapsule on investigator's exam or radiographic evidence
• Infection in the target ulcer requiring systemic antibiotic therapy
• Subjects receiving immunosuppressants (including systemic corticosteroids > 10 mgPrednisone per day or equivalent) or cytotoxic chemotherapy
• Topical application of steroids to the ulcer surface within one month of initialscreening
• Subjects with previous partial amputation on the affected foot that impedes properoffloading of the target ulcer
• Subjects with a glycated hemoglobin (HbA1c) greater than or equal to 13% taken at orwithin 3 months of the initial screening visit
• Subjects with a serum creatinine level ≥ 3.0mg/dL within 6 months of randomization
• Surface area of the target ulcer reduces in size by more than 30% in the two weeksbetween the initial screening and randomization during which they are subject tostandard of care
• Subjects with acute or inactive Charcot foot that impedes proper offloading of thetarget ulcer
• Women who are pregnant or considering becoming pregnant within the next 6 months
• Subjects with end stage renal disease requiring dialysis
• Subjects who participated in a clinical trial involving treatment with aninvestigational product within the previous 30 days
• Subjects who, in the opinion of the investigator, have a medical or psychologicalcondition that may interfere with study assessments
• Subjects treated with hyperbaric oxygen therapy or a cellular and/or tissue product (CTP) in the 30 days prior to the initial screening visit