Clinical study to evaluate the effects of human microvascular tissue in diabetic foot ulcers

INTERVENTION: Randomisation is performed using envelopes that have be prepared prior to the randomisation visits. Group 1: Standard of Care (SOC) Group 2: SOC + mVASC. mVASC is a minimally manipulated microvascular human tissue product. Study subjects are treated weekly for up to 12 weeks. Subjects receiving mVASC receive a quantity of mVASC appropriate to the size of their ulcer. A subject of subjects undergo LUNA imaging and biopsy at selected time points (baseline, six and 12 weeks). All subjects undergo wound imaging. CONDITION: Wagner 1 and 2 diabetic foot ulcers (DFUs) ; Injury, Occupational Diseases, Poisoning ; Wagner 1 and 2 diabetic foot ulcers (DFUs) PRIMARY OUTCOME: Percentage of index ulcers healed is measured using photographs of the index ulcer at baseline and 12 weeks. SECONDARY OUTCOME: 1. Percentage of index ulcers is measured using photographs at baseline and at 6 weeks; 2. Time to heal is measured using photographs at 6 and 12 weeks; 3. Percent Area Reduction (PAR) measured using photographs at 6 and 12 weeks; 4. Changes in peripheral neuropathy appendage area is measured using a probe and photographs at baseline and at 12 weeks; 5. Changes in wound quality of life (per W‐QoL) is measured using the validated W‐QofL instrument at baseline and at 12 weeks; 6. Change in pain levels during trial is measured using a visual analog scale (VAS) at baseline and at 12 weeks; 7. Difference in cellulitis and/or infection is measured using a visual scoring system at baseline and at 12 weeks INCLUSION CRITERIA: 1. At least 18 years old 2. Presence of a DFU, Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the tendon, muscle, or bone, on any aspect of the foot, provided it is below the medial aspect of the malleolus 3. The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot they must be more than 2 cm distant from the index ulcer 4. Index ulcer (i.e. current episode of ulceration) has been present for greater than four weeks prior to the initial screening visit and less than 1‐year, as of the date subject consents for study 5. Index ulcer is a minimum of 0.75 cm2 and a maximum of 25 cm2 at first screening visit (SV1) and first treatment visit (TV1) 6. Adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin