Numerous studies have demonstrated the various properties of micronized adipose tissue (MAT), including angiogenic, anti-inflammatory, and regenerative activities, which can be helpful in wound healing. This exploratory clinical trial aimed to report the efficacy and safety of MAT niche for treating diabetic foot ulcers. Twenty subjects were randomly divided into MAT niche treatment (n = 10) and control groups (n = 10). All patients were followed up weekly for 16 weeks. We evaluated the efficacy of the MAT niche treatment by assessing the (1) reduction in wound area after 4 weeks and (2) percentage of patients who achieved complete wound closure after 16 weeks. All possible adverse events were recorded. The wound area was reduced by 4.3 ± 1.0 cm² in the treatment group and by 2.0 ± 1.1 cm² in the control group (p = 0.043). Complete wound healing was achieved after 16 weeks in eight out of 10 patients (80%) in the treatment group and three out of six (50%) in the control group (p = 0.299). No serious adverse events related to MAT niche treatment were observed. Although the present study’s findings do not support the use of this therapy to treat foot ulcers of patients with diabetes owing to the small number of patients included and the absence of statistical significance, the results of this pilot preliminary study are promising in that MAT niche autografts may offer the possibility of a simple and effective treatment for diabetic ulcers. Further follow-up studies with a larger number of patients are required to validate our findings.

Background: In a previous study, we suggested that micronized adipose tissue (MAT) niche could be an effective and safe treatment for diabetic foot ulcers. Fibrin glue was used to solidify the MAT niches. However, it took 40 to 50 minutes for the MAT niche to be ready for application. We have devised an alternate method in which the MAT niche is created at a low temperature to reduce the solidification time. This pilot study aimed to investigate the possibility and safety of grafting a low-temperature MAT niche for treating diabetic foot ulcers.Methods: Patients with diabetic foot ulcers who were treated with low-temperature MAT or conventional methods between March 2020 and December 2021 were included in this study. We evaluated the efficacy of the treatment by measuring the wound size reduction rate. All adverse events were recorded.Results: The MAT niche treatment group showed a statistically significant wound reduction rate during the entire study period of 4 weeks (P<0.005). The wound reduction rates in the 4th week after the treatment were 75.7%±16.9% in the treatment group and 33.5%±19.0% in the control group (P=0.001). No serious adverse events related to low-temperature MAT niche treatment were observed.Conclusion: This pilot study demonstrated the potential of low-temperature MAT niche as an effective and safe method for the treatment of diabetic foot ulcers.