Unknown

Dataset Information

0

One-year safety, healing and amputation rates of Wagner 3-4 diabetic foot ulcers treated with cryopreserved umbilical cord (TTAX01).


ABSTRACT: An open label, multicenter 16-week trial of cryopreserved human umbilical cord (TTAX01) was previously undertaken in 32 subjects presenting with a Wagner grade 3 or 4 diabetic foot ulcer, with 16 (50%) of these having confirmed closure following a median of one product application (previous study). All but two subjects (30/32; 94%) consented to participate in this follow-up study to 1-year postexposure. No restrictions were placed on treatments for open wounds. At 8-week intervals, subjects were evaluated for adverse events (AEs) and wound status (open or closed). Average time from initial exposure to end of follow-up was 378?days (range 343-433), with 29 of 30 (97%) subjects completing a full year. AEs were all typical for the population under study, and none were attributed to prior exposure to TTAX01. One previously healed wound re-opened, one previously unconfirmed closed wound remained healed, and nine new wound closures occurred, giving 25 of 29 (86.2%) healed in the ITT population. Three of the new closures followed the use of various tissue-based products. Three subjects whose wounds were healed required subsequent minor amputations due to osteomyelitis, one of which progressed to a major amputation (1/29; 3.4%). One additional subject underwent two minor amputations prior to healing. Overall, the study found TTAX01 to be safe in long-term follow-up and associated with both a low rate of major amputation and a higher than expected rates of healing.

SUBMITTER: Marston WA 

PROVIDER: S-EPMC7383512 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

altmetric image

Publications

One-year safety, healing and amputation rates of Wagner 3-4 diabetic foot ulcers treated with cryopreserved umbilical cord (TTAX01).

Marston William A WA   Lantis John C JC   Wu Stephanie C SC   Nouvong Aksone A   Clements John Randolph JR   Lee Tommy D TD   McCoy Nicholas D ND   Slade Herbert B HB   Tseng Scheffer C SC  

Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society 20200509 4


An open label, multicenter 16-week trial of cryopreserved human umbilical cord (TTAX01) was previously undertaken in 32 subjects presenting with a Wagner grade 3 or 4 diabetic foot ulcer, with 16 (50%) of these having confirmed closure following a median of one product application (previous study). All but two subjects (30/32; 94%) consented to participate in this follow-up study to 1-year postexposure. No restrictions were placed on treatments for open wounds. At 8-week intervals, subjects were  ...[more]

Similar Datasets

| S-EPMC6900178 | biostudies-literature
2021-10-28 | GSE166120 | GEO
| S-EPMC6014539 | biostudies-literature
| S-EPMC9606988 | biostudies-literature
| S-EPMC7752820 | biostudies-literature
| S-EPMC7494323 | biostudies-literature
| S-EPMC3879594 | biostudies-literature
| PRJNA699294 | ENA
| S-EPMC7044945 | biostudies-literature
| S-EPMC10898407 | biostudies-literature