ORIGINAL ARTICLE  PERIPHERAL ARTERIAL DISEASE Free access

International Angiology 2021 December;40(6):512-9

DOI: 10.23736/S0392-9590.21.04570-3

Copyright © 2021 EDIZIONI MINERVA MEDICA

language: English

Health-related quality of life outcomes and hospitalization length of stay after micro-fragmented autologous adipose tissue injection in minor amputations for diabetic foot ulceration (MiFrAADiF Trial): results from a randomized controlled single-center clinical trial

Stefano GENNAI, Nicola LEONE ✉, Tea COVIC, Mattia MIGLIARI, Roberto LONARDI, Roberto SILINGARDI

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

BACKGROUND: 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.
METHODS: 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).
RESULTS: 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).
CONCLUSIONS: 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.

KEY WORDS: Amputation; Diabetes complications; Foot ulcer; Surgical procedures, operative; Stem cells; Adipose tissue