Clinical Research Directory

Inclusion Criteria: * 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 Exclusion Criteria: * 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). * 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 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. * Active malignancy or malignancy related limb amputation. * Women that are pregnant or planning to become pregnant during the study. * Patients with albumin levels less than 3.5 or prealbumin levels less than 18. * 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. * TWSB \> 30 cm2 (total wound surface burden)