Lipogems® Treatment Reduces Hospital Stay for Diabetic Foot Amputations
Stefano Gennai, Nicola Leone, Tea Covic, Mattia Migliari, Roberto Lonardi, Roberto Silingardi · International Angiology · 2021
Randomized Trial Tests Fat-Derived Cells After Toe Surgery
When diabetes leads to foot ulcers that won't heal, doctors sometimes must remove a toe or part of the foot. This study tested whether injecting micro-fragmented adipose tissue (MFAT)—specially processed fat from your own body—could help these wounds heal better. Researchers in Italy randomly assigned 114 patients to receive either the MFAT injection or standard wound care after minor foot amputation. The team then tracked patients for six months.
Treated Patients Went Home Eight Days Sooner
One of the most striking findings involved hospital stay length. Patients who received the MFAT injection stayed an average of 16.2 days. Those receiving standard care stayed 24.4 days—more than a week longer. This difference was statistically significant, meaning it wasn't due to chance. Going home sooner means less time away from family and daily routines.
Physical Function Scores Improved Significantly
The research team measured quality of life using a well-known health survey. This survey produces two main scores: one for physical functioning and one for mental/emotional health. Patients who received the MFAT injection showed meaningful improvement in their physical function scores. The type of treatment made a real difference in how well patients could move and perform daily activities during recovery.
Mental Health Improved Equally in Both Groups
Both groups showed better mental health scores as time passed after surgery. However, the MFAT treatment didn't provide extra mental health benefits compared to standard care. This suggests the emotional improvements came from general healing progress rather than the specific treatment type.
How the Treatment Works
The procedure involves two steps performed during the same surgery:
Doctors collect a small amount of fat tissue from the patient's abdomen or thigh
This fat is processed using the Lipogems® system to create micro-fragmented tissue
The processed tissue—containing pericytes (helper cells for blood vessels) and mesenchymal stem cells (regenerative cells)—is injected around the amputation wound
Because the tissue comes from your own body, there's no risk of rejection. The cells help support the natural healing process.
Study Design Adds Confidence to Results
This research used randomization, which means patients were assigned to treatment or control groups by chance. This approach helps ensure fair comparisons. All 114 participants had diabetes with foot ulcers requiring minor amputation. Before entering the study, each patient had blood flow testing to confirm adequate circulation to the foot.
What This Means for Patients with Diabetic Foot Ulcers
Diabetic foot complications affect millions worldwide. When minor amputation becomes necessary, proper wound healing is crucial. Wounds that don't heal well can lead to larger amputations. This trial suggests that MFAT injection offers two meaningful benefits:
Shorter hospital stays, reducing time away from normal life
Better physical function during the six-month recovery period
The treatment uses your body's own regenerative resources. It adds minimal time to the surgical procedure. For patients facing minor foot amputation due to diabetes, discussing this option with your medical team may be worthwhile.
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Source: Gennai et al., International Angiology, 2021.
Original Publication
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 · International Angiology · 2021
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.