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

Autor:	Stephanie C. Wu, Scheffer C. Tseng, Aksone Nouvong, William A. Marston, Nicholas D. McCoy, Herbert B. Slade, Tommy D. Lee, John C. Lantis
Rok vydání:	2019
Předmět:	Adult Male medicine.medical_specialty Pilot Projects Dermatology Risk Assessment Severity of Illness Index Umbilical cord Umbilical Cord 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Multicenter trial Biopsy medicine Humans Original Research‐Clinical Science Aged Foot osteomyelitis Cryopreservation Wound Healing medicine.diagnostic_test business.industry Osteomyelitis Fascia Middle Aged Prognosis medicine.disease Diabetic foot Diabetic Foot Surgery medicine.anatomical_structure Diabetic foot ulcer Debridement Diabetes Mellitus Type 2 Female business
Zdroj:	Wound Repair and Regeneration
ISSN:	1524-475X 1067-1927
DOI:	10.1111/wrr.12754
Popis:	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 weeks. Mean wound area reduction from baseline was 91% for all wounds. Of the 16 wounds without confirmed closure during the 16‐week treatment period, five (31.3%) achieved 99–100% wound area reduction by their final visit. The product was well tolerated. Two minor amputations occurred during the study period due to recurrent or persistent osteomyelitis; however, there were no major amputations.
Databáze:	OpenAIRE
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