Efficacy of hyperbaric oxygen therapy versus conventional therapy in the management of diabetic foot ulcers: a randomized controlled trial

Vollständiger Abstract

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Background: Diabetic foot ulcers (DFUs) are major complications of diabetes mellitus and a leading cause of morbidity, infection, and limb amputation worldwide. Hyperbaric oxygen therapy (HBOT) has been proposed as an effective adjunct to conventional wound care, but evidence regarding its comparative efficacy remains inconsistent. Objective: To compare the efficacy of hyperbaric oxygen therapy and conventional therapy in the management of diabetic foot ulcers. Study Design and Setting: Randomized controlled trial conducted at the Department of General Surgery, Pakistan Navy Station (PNS) Shifa Hospital, Karachi, over six months following synopsis approval. Methodology: A total of 102 patients with non-healing diabetic foot ulcers, aged 18–75 years, were enrolled through consecutive sampling and randomized using the lottery method into two equal groups of 51 patients each. Group 1 received conventional therapy (antibiotics and standard wound care), while Group 2 received adjunctive HBOT. Measures evaluated were reduction of ulcer size, infection control, and surgery necessity. Contextual Analysis Data were analyzed with the help of SPSS version 24.0 The Chi-square/Fisher Exact Test was carried out on categorical variables. A p-value ≤ 0.05 was considered statistically significant. Findings: Baseline was well matched in both groups (all p >.05). The decrement in ulcer size was much stronger in the HBOT group (44.1% vs 23.5, p = .012). There was a positive trend favoring infection control with HBOT (45.1% vs 37.3%) although not statistically significant (p =. 091). The surgical intervention was also significantly reduced in the HBOT group (5.9% vs 25.5%, p = .013). Conclusion: Adjunctive HBOT proved to have a major impact on ulcer healing and decrease in surgical intervention rates in diabetic foot ulcer patients over conventional therapy. These results favor its consideration as an evidence-based supplement in the treatment of diabetic foot ulcers.