A Pilot Study Comparing a Micronized Adipose Tissue Niche versus Standard Wound Care for Treatment of Neuropathic Diabetic Foot Ulcers

Abstract

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.

Keywords: diabetic foot; micronized adipose tissue.

Figure 1

CONSORT diagram showing the flow of patients included in this study.

Figure 2

A diagram showing the flow of patients in the treatment group in this study.

Figure 3

The mean wound area from baseline to the 4 week visit. The wound size was reduced by 4.3 ± 1.0 cm² (mean ± SD) and 2.0 ± 1.1 cm² in the treatment and control groups, respectively. The reduction rates were 77.1% ± 4.9% and 45.7% ± 15.6% in the treatment and control groups, respectively.

Figure 4

Total number of patients with completely closed wounds at 4, 8, 12, and 16 weeks. Complete wound closure was achieved in 10%, 40%, 70%, and 80% of patients in the treatment group and in 16.7%, 16.7%, 16.7%, and 50.0% of patients in the control group at 4, 8, 12, and 16 weeks, respectively.

Figure 5

A 70 year old man with diabetes mellitus had a nonhealing ulcer on his right foot for 8 weeks. A micronized adipose tissue niche was applied to the wound.

Figure 6

Three representative examples of micronized adipose tissue niche grafts of diabetic foot ulcers. Baseline: before treatment. Final: after treatment at the first closure at 6, 10, and 11 weeks in Patients (A), (B), and (C), respectively).

Figure 7

Kaplan–Meier diagram showing results of the time to wound closure. The Kaplan–Meier median times to complete closure were 10.2 ± 1.4 and 13.3 ± 1.9 weeks in the treatment and control groups, respectively.