An open-label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis

Wound Repair and Regeneration : Official Publication of the Wound Healing Society [and] the European Tissue Repair Society
William A MarstonScheffer C Tseng

Abstract

Clinical trials of potential new therapies for diabetic foot ulcers rarely enroll patients whose wounds extend to muscle, fascia, or bone with clinical and radiographic evidence of underlying osteomyelitis. An open-label, multicenter trial of cryopreserved human umbilical cord (TTAX01) was undertaken in 32 subjects presenting with such complex wounds with a mean duration of 6.1 ± 9.0 (range: 0.2-47.1) months and wound area at screening of 3.8 ± 2.9 (range: 1.0-9.6) cm2 . Aggressive surgical debridement at baseline resulted in 17 minor amputations and an increase in mean wound area to 7.4 ± 5.8 (range: 1.1-28.6) cm2 . All subjects were placed on systemic antibiotics for at least 6 weeks in conjunction with baseline application of TTAX01. Repeat applications were made at no less than 4-week intervals over the 16-week trial. Initial closure occurred in 18 of 32 (56%) wounds, with 16 (50%) of these having confirmed closure in 16 weeks with a median of one-product application. Cases with biopsy confirmed osteomyelitis (n = 20) showed initial closure in 12 (60%) wounds and confirmed closure in 10 (50%) wounds. Four of the five ulcers presenting as recurrences experienced confirmed closure. Mean overall time to healing was 12.8 ± 4.3 ...Continue Reading

References

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Citations

Apr 21, 2020·Taiwan Journal of Ophthalmology·Scheffer C G Tseng
Mar 27, 2020·Frontiers in Bioengineering and Biotechnology·Francesca VelardeAndrés Caicedo
May 10, 2020·Wound Repair and Regeneration : Official Publication of the Wound Healing Society [and] the European Tissue Repair Society·William A MarstonScheffer C Tseng
Aug 17, 2020·Experimental Eye Research·Scheffer C G TsengSean Tighe

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Methods Mentioned

BETA
amputation
surgical resection
biopsies
biopsy
amputations

Clinical Trials Mentioned

NCT03230175

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