Diabetology Department, Center Hopitalier Sud Francilien, Corbeil-Essonnes, France.
LBEPS, Université d'Evry, IRBA, Université Paris Saclay, 91025 Evry, France.
NEJM Evid. 2024 Dec;3(12):EVIDoa2400171. doi: 10.1056/EVIDoa2400171. Epub 2024 Oct 4.
Diabetic foot ulcers are chronic, difficult to heal, and potentially life-threatening. Few medical devices have been studied in diabetic ulcers penetrating to bone or tendon.
We conducted an international, open-label randomized controlled trial, randomly assigning patients with diabetic ulcers penetrating to bone, joint, or tendon 1:1 to intact fish skin graft or standard wound care, with assigned treatment applied through 14 weeks. The primary end point was the proportion of ulcers healed at 16 weeks, defined as reepithelization as identified by the investigator, and confirmed 14 days later. A blinded adjudication committee confirmed healing at both time points. Healing was also assessed at 20 and 24 weeks.
Between July 2020 and November 2022, 255 patients were randomly assigned to intact fish skin graft (n=129) or standard of care (n=126). Healing was achieved in 44% of patients at 16 weeks with intact fish skin graft compared with 26% for standard of care (P<0.001, unadjusted), with additional healing at 20 weeks (46% vs. 32%) and 24 weeks (55% vs. 38%). Mean (SD) time to healing was 17.3 (0.69) weeks (95% confidence interval [CI], 15.5 to 18.7) for the intact fish skin graft group and 19.4 (0.66) weeks (95% CI, 18.1 to 20.7) for the standard of care group. In a Cox regression, intact fish skin graft was associated with faster time to healing (hazard ratio, 1.59; 95% CI, 1.07 to 2.36). Primary wound infections were the most common adverse event, occurring in 39 (30.2%) of patients in the intact fish skin graft group and 31 (24.6%) of patients in the standard of care group.
Among patients with deep diabetic foot ulcers, treatment with intact fish skin graft was superior to standard of care in proportion of wounds healed at 16 weeks and was associated with faster time to healing. (Funded by European Commission Fast Track to Innovation Horizon 2020, and Kerecis Ltd. ClinicalTrials.gov NCT04257370.).
糖尿病足溃疡是一种慢性、难以愈合且可能危及生命的疾病。目前很少有医学设备被研究用于治疗穿透骨骼或肌腱的糖尿病足溃疡。
我们进行了一项国际性、开放性、随机对照试验，将穿透骨骼、关节或肌腱的糖尿病足溃疡患者以 1:1 的比例随机分配至完整的鱼皮移植物或标准伤口护理组，通过 14 周的治疗时间接受分配的治疗。主要终点是在 16 周时溃疡愈合的比例，定义为研究者确定的再上皮化，并在 14 天后确认。一个盲法裁决委员会在两个时间点都确认了愈合。愈合情况也在 20 周和 24 周进行评估。
2020 年 7 月至 2022 年 11 月期间，255 名患者被随机分配至完整的鱼皮移植物组（n=129）或标准护理组（n=126）。在 16 周时，完整的鱼皮移植物组有 44%的患者实现了愈合，而标准护理组为 26%（P<0.001，未调整），在 20 周和 24 周时也有更多的愈合（46%比 32%，55%比 38%）。完整的鱼皮移植物组的平均（SD）愈合时间为 17.3（0.69）周（95%置信区间[CI]，15.5 至 18.7），标准护理组为 19.4（0.66）周（95%CI，18.1 至 20.7）。在 Cox 回归中，完整的鱼皮移植物与更快的愈合时间相关（风险比，1.59；95%CI，1.07 至 2.36）。原发性伤口感染是最常见的不良事件，在完整的鱼皮移植物组中有 39（30.2%）例患者和标准护理组中有 31（24.6%）例患者发生。
在穿透性糖尿病足溃疡患者中，与标准护理相比，完整的鱼皮移植物治疗在 16 周时的愈合比例更高，并且与更快的愈合时间相关。（由欧盟委员会快速创新轨道 2020 地平线资助，Kerecis Ltd.。ClinicalTrials.gov NCT04257370.）。
