Diabetic Foot Unit, Clínica Universitaria de Podología, Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
Global Medical Affairs Director, Laboratoires URGO, Paris, France.
Int Wound J. 2024 Oct;21(10):e70028. doi: 10.1111/iwj.70028.
To compare recurrence rates after a 1-year follow-up period of healed neuroischemic diabetic foot ulcers after treatment with or without sucrose octasulfate impregnated dressing. A 1-year prospective study with two arms was conducted between April 2021 and April 2023 on 92 patients with healed neuroischemic diabetic foot ulcers. Patients were divided into two groups; the treatment group, that includes patients healed with a sucrose octasulfate-impregnated dressing, and the control group, which includes patients treated with other local treatments different from sucrose octasulfate-impregnated dressings. After healing, patients were prospectively followed up during 1-year and assessed monthly in the specialised outpatient clinics. The main outcome of the study was ulcer recurrence after wound healing within 1 year follow-up. Secondary outcomes were minor or major amputation and all causes of death. Fifty patients in the treatment group and 42 patients in the control group were included. Fourteen (28%) patients suffered from a reulceration event in the treatment group compared to 28 (66.7%) in the control group, p < 0.001. Time to recurrence in the treatment group was 10 (16.26-2.75) and 11.50 (30.75-5.25) weeks in the control group, p = 0.464. There were no observed differences in the minor amputation rates between the two groups: 15.2% (n = 7) in the treatment group and 7.1% (n = 3) in the control group (p = 0.362). Major amputations and death outcomes were exclusively observed in the treatment group. Specifically, four major amputations (8.7%) in the treatment group were complications arising from recurring events complicated by infection during the SARS-CoV-2 period. Seven patients died due to complications not related with local therapy. The relative risk of recurrence was 20.18 times higher in the control group compared with those treated with octasulfate dressing (p < 0.001). Treatment with sucrose octasulfate-impregnated dressings can decrease recurrence rates of neuroischaemic diabetic foot ulcers more effectively than neutral dressings. Besides, it may enhance the foot's clinical properties in patients with poor microcirculation, which could aid in preventing future recurrences.
比较在神经缺血性糖尿病足溃疡愈合后 1 年随访期内，接受或不接受硫酸八聚糖浸渍敷料治疗后的复发率。这是一项 2021 年 4 月至 2023 年 4 月进行的为期 1 年、有 2 个分支的前瞻性研究，共纳入 92 例神经缺血性糖尿病足溃疡愈合患者。将患者分为两组；治疗组，即使用硫酸八聚糖浸渍敷料愈合的患者，和对照组，即使用与硫酸八聚糖浸渍敷料不同的局部治疗的患者。愈合后，患者在 1 年内进行前瞻性随访，并在专门的门诊每月进行评估。该研究的主要结果是在 1 年随访期间愈合后的溃疡复发。次要结果是小截肢或大截肢以及所有死因。治疗组 50 例，对照组 42 例。治疗组有 14 例（28%）发生溃疡复发，对照组有 28 例（66.7%），p<0.001。治疗组的复发时间为 10 周（16.26-2.75），对照组为 11.50 周（30.75-5.25），p=0.464。两组小截肢率无差异：治疗组 15.2%（n=7），对照组 7.1%（n=3），p=0.362。大截肢和死亡结果仅在治疗组观察到。具体而言，治疗组有 4 例（8.7%）大截肢是在 SARS-CoV-2 期间因复发事件并发感染引起的并发症。有 7 名患者因与局部治疗无关的并发症而死亡。与对照组相比，接受八聚糖敷料治疗的患者复发风险高 20.18 倍（p<0.001）。与中性敷料相比，硫酸八聚糖浸渍敷料治疗可更有效地降低神经缺血性糖尿病足溃疡的复发率。此外，它可能会增强微循环不良患者的足部临床特性，有助于预防未来的复发。
