Placental Cells for Diabetic Foot Ulcers

Who can take part

• Diagnosed with Type 2 Diabetes mellitus (DM) - for at least 1 year
• Unilateral non-healing Diabetic Foot Ulcer (DFU) > 2 cm2 and ≤ 4 cm2 (length × width) for at least four weeks despite Atrium Health Wake Forest Baptist standard of care treatment (which can include total contact cast, knee high air cast, and/or compression wrap)
• No new diabetes medication for at least 2 weeks pre-treatment
• Subjects must be willing to avoid steroids for the week prior to procedure day

Who cannot take part

• Clinical signs of active infection requiring systemic antibiotic therapy less than 7 days prior to enrollment
• Radiographic or clinical evidence of active and untreated osteomyelitis at the target ulcer site. Current use of systemic immunosuppressive therapy, including chronic corticosteroids (equivalent to >10 mg/day prednisone for >14 days)
• Active malignancy or malignancy related limb amputation
• Subjects with any conditions that the clinical Investigator believes may jeopardize the safety of the patient to participate in the trial
• Severe peripheral arterial disease (PAD) (Ankle-Brachial Index (ABI) less than 0.5) or TCOM (Transcutaneous Oximetry Measurement) less than 40 mmHg
• Hemoglobin (Hgb) A1C >12.0 at screening or time in range for the blood glucose level (TIR) less than 30%. Hb A1c should not be used for patient with hypoalbuminemia or anemia in the past 3 months and for patients with Chronic Kidney disease stage 4. For patients who have Continuous Glucose Monitor (CGM), instead of Hb A1c, TIR (time in range) less than 30 % will be used
• Patients with albumin levels less than 3.5 or prealbumin levels less than 18
• Patients who are unable / unwilling to tolerate an effective offloading approach. This includes total contact cast, soft felted cast or knee high fracture boot
• Current alcohol or substance abuse that, in the opinion of the investigators, would interfere with study participation
• Women that are pregnant or planning to become pregnant during the study
• TWSB > 30 cm2 (total wound surface burden)