Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)

TTAX01 will be applied directly to the wound surface and retained with non-absorbable sutures. A single layer of the test article should cover the entire open surface of the wound. The material is to be applied once every 4 weeks unless the wound shows evidence of healing, in which case dosing is suspended; or, if the test article has been accidentally dislodged, it may be replaced at any time.

"Perform surgical sharp debridement in the OR, to remove:~* infectious agents and biofilms (purulence),~* all debris, eschar, callus and macerated non-viable tissue from the wound base, and~* dead (suprabasal epidermis), scarred (elevated/edematous) and necrotic/macerated tissue from the wound edge.~Surgical Resection will be performed to remove as much of the necrotic bone detected by the radiographic evidence as is appropriate."

Six (6) weeks of systemic antibiotic therapy is required. A definitive therapy will be guided by the microbiological results based on bone biopsy.

Provide off-loading device appropriate to the location of wound with full length boot or total contact cast