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.
Int Angiol
; 40(6): 512-519, 2021 Dec.
Article
en En
| MEDLINE
| ID: mdl-34515448
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 11 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.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Pie Diabético
/
Diabetes Mellitus
Tipo de estudio:
Clinical_trials
/
Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
Int Angiol
Año:
2021
Tipo del documento:
Article
País de afiliación:
Italia