Clinical Trial Information

Description of Trial:

A Multicenter Phase 3 Confirmatory Trial of Biotherapy using Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non Healing Diabetic Foot Ulcers (AMBULATE DFU II)

Protocol Number: TTAX01-CR005

Synopsis: This trial is seeking patients with diabetes who have a foot ulcer/sore/wound. Approximately 60% of these ulcers become infected resulting in a significant risk for hospitalization, surgery and amputation. The longer a wound is open, the greater the risk of bone infection or osteomyelitis. Many diabetic foot ulcers are difficult to heal due to unrecognized underlying bone infection. This trial calls for the limited and targeted surgical resection of the infected bone and topical application of an umbilical graft directly to the wound in order to promote healing of the wound. All study related procedures and treatment is at no cost to the patient. Financial compensation for time and travel is offered.

Status: Currently Enrolling Patients