Clinical Outcomes and Characterisation of the Autologous Adipose Tissue Harvested With Superficial Enhanced Fluid Fat Injection Method for Treatment of Diabetic Foot Ulcer Undergoing Minor Amputation (SEFFIDiFA Trial).

Early human evidence such as case series or small samples is exploring possible benefits.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Diabetic foot ulcers (DFUs) are severe complications of diabetes that often lead to major amputations. Despite care advancements, approximately 50% of minor amputations do not heal, resulting in major amputations and increased mortality. This study evaluated the effectiveness of adipose-derived stem cells (ASCs) obtained through superficial enhanced fluid fat injection (SEFFI) in improving healing rates after minor amputations in DFUs. It was a prospective, single-arm, observational cohort study. The patients were monitored for half a year using monthly assessments. The primary endpoint was the healing rate of the amputation stumps after minor amputations coupled with ASC injections. Secondary endpoints included safety, feasibility, adverse events and analysis of variables associated with healing including the analysis of the injected mesenchymal adipose stem cell populations. Of the 256 screened patients, 40 were enrolled. At 6 months, 55% of the treated stumps had healed completely. The median healing time was 69 days. Technical success was achieved in all cases without device-related complications. Multivariable Cox models identified haemodialysis, opioid use and the injected number of CD45-positive cells as risk factors for healing failure. CD73 expression was positively associated with healing. The SEFFIDiFA trial demonstrated a promising 69% healing probability at 6 month

Evidence level

Early human evidence such as case series or small samples is exploring possible benefits.

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