Division of Vascular Surgery, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
Department of Surgery, Mt Sinai West and St Luke's Hospitals, New York, New York.
Wound Repair Regen. 2019 Nov;27(6):680-686. doi: 10.1111/wrr.12754. Epub 2019 Aug 19.
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) cm . 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) cm . 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.
临床研究很少招募患有糖尿病足溃疡的患者，这些患者的伤口延伸至肌肉、筋膜或骨骼，且有临床和影像学证据表明存在骨髓炎。一项开放标签、多中心的冷冻人脐带（TTAX01）临床试验纳入了 32 名患有此类复杂伤口的患者，这些患者的伤口平均持续时间为 6.1±9.0（范围：0.2-47.1）个月，筛选时的伤口面积为 3.8±2.9（范围：1.0-9.6）cm。基线时进行积极的外科清创导致 17 例小截肢，平均伤口面积增加至 7.4±5.8（范围：1.1-28.6）cm。所有患者均接受了至少 6 周的全身抗生素治疗，并在基线时使用 TTAX01。在 16 周的试验中，每 4 周至少重复应用一次。32 例患者中有 18 例（56%）伤口初次闭合，其中 16 例（50%）在 16 周时通过活检确认闭合，中位数应用次数为 1 次。经活检证实有骨髓炎的病例（n=20）中，12 例（60%）伤口初次闭合，10 例（50%）伤口在 16 周时通过活检确认闭合。5 例复发性溃疡中有 4 例经活检证实闭合。总的愈合时间平均为 12.8±4.3 周。所有伤口的平均伤口面积从基线减少了 91%。在 16 周的治疗期间，没有通过活检确认闭合的 16 个伤口中，有 5 个（31.3%）在最后一次就诊时伤口面积减少了 99-100%。该产品耐受性良好。在研究期间，由于骨髓炎复发或持续存在，有 2 例患者进行了小截肢，但没有进行大截肢。
