Negative-pressure wound therapy compared with advanced moist wound therapy: A comparative study on healing efficacy in diabetic foot ulcers.

OBJECTIVE

This randomized controlled trial aimed to compare the efficacy of negative-pressure wound therapy with advanced moist wound therapy in managing diabetic foot ulcers.

METHODS

A total of 450 participants with diabetic foot ulcers were randomized to receive either negative-pressure wound therapy (n = 204) or advanced moist wound therapy (n = 246) over 18 months. The primary outcome was complete ulcer closure, with secondary outcomes including time to closure, wound size reduction, infection rates, recurrence, and amputation rates. Wound dimensions were measured using digital planimetry, and Kaplan-Meier survival analysis was applied to assess time to closure.

RESULT

Analysis revealed statistically significant differences in clinical outcomes between treatment modalities. In the negative-pressure wound therapy group (n = 204), complete ulcer closure was achieved in 177 patients (87%), which was significantly greater than the advanced moist wound therapy group (n = 246) with 72 patients (29%) (P < .001). Although the mean time to wound closure was marginally extended in the negative-pressure wound therapy group (73 ± 45 days vs 64 ± 49 days; P = .045), this cohort demonstrated substantially more significant wound area reduction (48% ± 15 vs 25% ± 30; P < .001). Secondary outcome analysis revealed that negative-pressure wound therapy was associated with markedly reduced adverse events: wound infection (40 patients [20%] vs 95 patients [39%]; P < .001), ulcer recurrence (40 patients [20%] vs 113 patients [46%]; P < .001), and amputation rates (30 patients [15%] vs 132 patients [54%]; P < .001). Longitudinal assessment through Kaplan-Meier survival analysis demonstrated significantly greater wound closure probability and reduced complication risk in the negative-pressure wound therapy group throughout the follow-up period (log-rank P < .001).

CONCLUSION

Negative-pressure wound therapy is significantly more effective than advanced moist wound therapy in treating diabetic foot ulcers, demonstrating superior outcomes in wound closure, infection control, and amputation prevention. This study highlights negative-pressure wound therapy as the preferred treatment option for complex diabetic foot ulcers, warranting further research into its long-term benefits and cost-effectiveness.