Department of Vascular Surgery, Ospedale Civile di Baggiovara, Azienda Ospedaliero-Universitaria di Modena, University Hospital of Modena, University of Modena and Reggio Emilia, Modena, Italy.
Department of Vascular Surgery, Ospedale Civile di Baggiovara, Azienda Ospedaliero-Universitaria di Modena, University Hospital of Modena, University of Modena and Reggio Emilia, Modena, Italy -
Int Angiol. 2021 Dec;40(6):512-519. doi: 10.23736/S0392-9590.21.04570-3. Epub 2021 Sep 13.
The diabetic foot ulcer (DFU) is a high prevalence complication that significantly impairs the health-related quality of life (HRQoL) and is characterized by prolonged hospital length of stay (LOS). The impact of the micro-fragmented autologous adipose tissue injection at the minor amputation wound in the case of DFU (MiFrAADiF) on HRQoL and LOS compared to the standard care has not been determined yet.
This was a two-arm, 6-month, individually-randomized controlled single-center clinical trial. A 1:1 randomization to local injection of autologous micro-fragmented adipose tissue (treatment group; N.=57) or standard clinical care (control group; N.=57) was performed. The primary objective was the HRQoL. The secondary endpoint was the LOS. HRQoL was assessed with the Medical Outcomes Study 36-item Short-Form Health Survey which provides 2 scores focused on physical (PCS) and mental functioning (MCS). The trial was registered in ClinicalTrials.gov (NCT03276312).
The type of treatment (P=0.009) and the time elapsed since surgery (P=0.0000) demonstrated a significant improvement on PCS. The MCS improvements resulted in a non-significant association with treatment (P=0.21). The time elapsed since surgery showed a significant influence on the MCS (P=0.0000). The mean LOS was 16.2 days and 24.4 days for the treatment and the control group respectively (P=0.025).
The MiFrAADiF Trial demonstrated a significant improvement in terms of physical HRQoL and a significant reduction of the hospital length of stay after injection of micro-fragmented autologous adipose tissue in diabetic patients' minor amputations wound.
糖尿病足溃疡（DFU）是一种高发并发症，严重影响患者的健康相关生活质量（HRQoL），并具有延长住院时间（LOS）的特点。DFU 患者小截肢伤口处注射微碎片自体脂肪组织（MiFrAADiF）对 HRQoL 和 LOS 的影响与标准护理相比尚未确定。
这是一项为期 6 个月的、个体随机对照、单中心的临床试验，采用 1:1 随机分组，局部注射自体微碎片脂肪（治疗组；N=57）或标准临床护理（对照组；N=57）。主要终点是 HRQoL，次要终点是 LOS。采用医疗结局研究 36 项简短健康调查（SF-36）评估 HRQoL，该调查提供 2 个关注身体功能（PCS）和精神功能（MCS）的评分。该试验在 ClinicalTrials.gov 注册（NCT03276312）。
治疗类型（P=0.009）和手术时间（P=0.0000）对 PCS 有显著改善。MCS 的改善与治疗无显著相关性（P=0.21）。手术时间对 MCS 有显著影响（P=0.0000）。治疗组和对照组的平均 LOS 分别为 16.2 天和 24.4 天（P=0.025）。
MiFrAADiF 试验表明，在糖尿病患者小截肢伤口处注射微碎片自体脂肪后，患者的生理 HRQoL 有显著改善，住院时间显著缩短。
