Healing of diabetic neuropathic foot ulcers receiving standard treatment in randomised controlled trials: A random effects meta-analysis

Wound Repair Regen. 2025 Jan-Feb;33(1):e13237. doi: 10.1111/wrr.13237.

Abstract

This meta-analysis aimed to systematically assess and synthesise healing rates within a 12- to 24-week treatment period among patients with diabetic foot ulcers receiving standard-of-care interventions in randomised controlled trials. This meta-analysis included 32 randomised controlled trials conducted between 1996 and 2023, with sample sizes ranging from 9 to 169 patients. A random-effects model was applied to estimate pooled healing and infection rates. Heterogeneity was quantified using the I2 statistic, and publication bias was assessed using Egger's test. The results revealed a pooled healing rate of 33.15% with a 95% confidence interval (CI) of 31.18%-35.11% and an average healing time of approximately 50.14 days (standard deviation: 31.10 days). The infection proportion was determined to be 17.4% (95% CI: 12.2%-22.5%). Subgroup analysis indicated marginally higher healing rates in the 'Saline Gauze' group compared to the 'Alginate' group, although the latter exhibited a reduced infection proportion. Sensitivity analysis affirmed the robustness of these findings whereas Egger's test suggested the presence of potential publication bias concerning the healing outcomes. The standard-of-care interventions for diabetic foot ulcers demonstrate limited effectiveness, with only about one-third of patients achieving wound closure. The significant heterogeneity and publication bias observed necessitate a cautious interpretation of these results. The findings highlight the need for advanced wound care strategies and personalised treatment plans to improve outcomes in diabetic foot ulcers management. Future research should focus on conducting high-quality, well-reported randomised controlled trials to better understand effective treatments for DFUs.

Keywords: diabetic foot ulcer; healing; meta‐analysis; randomized controlled trial; standard of care.

Publication types

  • Meta-Analysis
  • Review

MeSH terms

  • Diabetic Foot* / therapy
  • Humans
  • Randomized Controlled Trials as Topic
  • Wound Healing*