Clinical Research Directory

Inclusion Criteria: * Participant and social support (e.g., family, caregiver) ready and willing to participate and comply with follow-up regime * Participant willing to be involved in self-care (e.g., keep dressing dry at home) required during treatment * Participant willing to wear Total Contact Cast (TCC) for wound off-loading during treatment * Participant or legal representative has read and signed the informed consent form * Documented stable Type I or II diabetes (HbA1C between 5.0 to 10 mmol/L within 1 month prior to Day 0) * Ulcer has been present for a minimum of 2 weeks as of Day 0 * Ulcer area is ≥2 cm2 prior to debridement at Day 0 of study * Ulcer extends through dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone or joint capsule * Ulcer is free of dead tissue and clinical infection, and is comprised of healthy vascular tissue suitable for skin grafting on Day 0 * Adequate perfusion to the extremity determined by at least one of the following: Palpable pedal pulses, Transcutaneous oxygen measurement at the dorsum of the foot ≥30 mm Hg, Ankle-brachial index ranging from 0.8 to 1.2, At least biphasic Doppler arterial waveforms at the dorsalis pedis and posterior tibial arteries Exclusion Criteria: * The individual has any condition that seriously compromises their capacity to provide consent and answers questions related to this study. * Untreated infection of soft tissue or bone and/or autoimmune connective tissue disorders * Ulcer is over Charcot deformity (joints deformity of foot and ankle common in people with diabetes) * Body mass index ≥50 kg/m2 * Ulcer is not classified as diabetes-related * Ulcer has tunnels or sinus tracts that cannot be completely debrided * Medical condition(s) that in the investigators' opinion make the patient inappropriate for study (e.g active liver disease) * Presence of malignant disease not in remission for 5 years or more * The individual is undergoing chemotherapy/radiation therapy * The individual received radiation therapy within 30 days of Day 0 of study * The individual is taking an immunosuppressant medication (e.g., corticosteroids, immunosuppression or cytotoxic agents), or is anticipated to require such agents during study * Presence of acute or chronic hepatitis, liver disease, anemia, serum albumin \<2.0 gm/dL, or has alkaline phosphatase or LDH at twice the normal upper limit * Obvious clinical signs and symptoms of ongoing tissue infection (i.e., cellulitis) or bone infection (i.e., osteomyelitis) * Female individuals are pregnant at time or intend to get pregnant during study time * The individual has known allergies to antibiotics, such as penicillin and streptomycin * The individual is an active smoker (smoke one or more cigarette a day) * The individual has a history of a bleeding disorder or is taking blood thinner medication