Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC

Inclusion criteria

• Subject is at least 18 years of age
• Diabetic Foot Ulcer Only - Subject has diagnosed Type 1 or Type 2 diabetes
• Subject's wound is located on foot or ankle (DFU) or leg (VLU)
• Subject has diabetic foot ulcer > 1.0 cm2 and ≤ 25 cm2 OR venous leg ulcer > 1.0 cm2 and ≤ 50 cm2
• Subject has adequate circulation to affected extremity with TcPO2 results of ≥ 40 mm Hg on the dorsum of the affected foot or ABI results ≥ 0.7 and≤ 1.2 or Great Toe Pressure ≥ 50 mmHg
• Subject is willing and able to comply with all protocol requirements
• Subject is willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)

Exclusion criteria

• Subject is pregnant
• Subject with diagnosed diabetes has HbA1C > 12 within 3 months Prior to randomization
• Subject has > 30% reduction in wound size after 2-week run-in period
• Subject has active infection, undrained abscess, or critical colonization of the wound with bacteria
• Subject has osteomyelitis or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or MRI
• Subject is on parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during 30 days before screening. Chronic oral steroid use is not excluded if dose < 10 mg per day of prednisone
• Subject is currently undergoing cancer treatment
• Subject has used biologic skin substitutes within 14 days of enrollment
• Subject has an allergy to suture material
• Subject has life expectancy less than six-months as assessed by the investigator
• Subject is participating in another clinical research study prior to this study completion