At a glance
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A Multicenter, Open Label Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)
In Brief
A Phase 2 clinical trial evaluating TTAX01, Surgical resection and debridement, and 2 other interventions for Non-healing Wound and 2 related conditions. Completed, enrolled 32 participants across 11 sites.
Detailed Summary
It is hypothesized that application of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer will, with concomitant management of infection, result in a higher proportion of wounds showing complete healing within 16 weeks of initiating therapy.
Study Details
Timeline
Interventions
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