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

Abstract

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.

Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: A systematic review

“…The main finding was a significant improvement in HRQoL between those who healed and those who did not. The pre‐planned HRQoL assessment of a study of autologous lipoaspirates 203 was published in a separate report 211 . Using the SF36, they assessed HRQoL in the domains of physical component and mental component summaries.…”

“…The pre-planned HRQoL assessment of a study of autologous lipoaspirates 203 was published in a separate report. 211 Using the SF36, they assessed HRQoL in the domains of physical component and mental component summaries. Per protocol analysis only was performed of this study with no blinding of participants or outcome measures and overall the study was assessed as being at high risk of bias.…”