One‐year safety, healing and amputation rates of Wagner 3‐4 diabetic foot ulcers treated with cryopreserved umbilical cord ( TTAX01 )
Autor: | Nicholas D. McCoy, Stephanie C. Wu, Aksone Nouvong, John C. Lantis, Scheffer C. Tseng, William A. Marston, Tommy D. Lee, Herbert B. Slade, John Randolph Clements |
---|---|
Rok vydání: | 2020 |
Předmět: |
Adult
Male medicine.medical_specialty medicine.medical_treatment Population Dermatology Severity of Illness Index Umbilical cord Amputation Surgical Cryopreservation Umbilical Cord 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine medicine Humans Original Research‐Clinical Science Adverse effect education Aged Biological Products Wound Healing education.field_of_study business.industry Osteomyelitis Middle Aged medicine.disease Diabetic foot Diabetic Foot Surgery Treatment Outcome Diabetic foot ulcer medicine.anatomical_structure Amputation Female business Follow-Up Studies |
Zdroj: | Wound Repair and Regeneration |
ISSN: | 1524-475X 1067-1927 |
Popis: | 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. |
Databáze: | OpenAIRE |
Externí odkaz: | |
Nepřihlášeným uživatelům se plný text nezobrazuje | K zobrazení výsledku je třeba se přihlásit. |