Phase 2 Trial Of Human Umbilical Cord For Complex Non-healing Diabetic Foot Ulcers
Herbert B. Slade, Tommy D. Lee, Nick McCoy, Scheffer Tseng.
Tissuetech Inc, FORT WORTH, TX, USA.
BACKGROUND - This open label Ph2 study was carried out in adults with complex DFU, defined as positive probe to bone and radiographic evidence of osteomyelitis. METHODS - The study engaged 11 sites to enroll 32 of 30 planned adult diabetics (HbA1c <12%) with an ulcer on the foot excluding the dorsum, of 1.0 - 10.0 cm2 initial area at screening, with ABI ≥0.7 to ≤1.3. See NCT03230175 for full criteria. Aggressive surgical debridement included removal of infected / devitalized bone and tissue, with bone sent for histopath confirmation. Systemic antibiotics were to be used for 6 weeks. TTAX01 human umbilical tissue was sutured or stapled to the wound bed following the initial procedure. Secondary dressings were at the Investigator’s discretion. All subjects were instructed to offload their wounds. Repeat application of TTAX01 was permitted at a minimum of 4 week intervals only for wounds that were not progressing towards healing. RESULTS - One subject withdrew consent early, one was unable to receive all applications due to supply interruption. >50% of the remaining 30 achieved initial closure in 16 weeks, including all cases presenting with gangrene (n=3) and 75% of cases >12 m duration (n=4). Only 2 subjects experienced recurrent osteomyelitis. An average of ~ 1.5 applications were used in subjects achieving closure. Mean time to heal was 10.4 weeks (range 6 - 16). No adverse events were attributed to the TTAX01. CONCLUSIONS - Closure rates are encouraging in this population with very difficult to treat wounds. The protocol for a planned Ph3 confirmatory trial will be adjusted based on learnings in Ph2.
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