Severity-Stratified Healing Outcomes of Nurse-Managed Negative Pressure Wound Therapy in Diabetic Foot Ulcers: A Prospective Comparative Cohort Study.

Abstract

Aim: To compare healing outcomes of nurse-managed negative pressure wound therapy (NPWT) and standard wound care (SWC) across baseline wound severity levels classified using the Suriadi, Haryanto, Imran Dan Defa (SHID) system in patients with diabetic foot ulcers (DFUs).

Design: A prospective quasiexperimental comparative cohort study.

Methods: This study was conducted at Kitamura Clinic between June and December 2025. Sixty-three patients with DFUs were enrolled in this study (NPWT, n = 31; SWC, n = 32). Wound severity was assessed using the SHID classification system, and wound progression was monitored weekly using the depth, maceration, infection, size, tissue type, and tunnelling. The primary outcome was time to complete wound healing within 12 weeks. Kaplan-Meier survival and Cox proportional hazards regression analyses were performed. A multivariable Cox model stratified by SHID stage accounted for baseline wound severity.

Results: Median healing time was significantly shorter in the NPWT group than in the SWC group (31 [13-70] vs. 81.5 [31-127] days, p < 0.001). All patients in the NPWT group achieved complete healing within 12 weeks compared with 50% in the SWC group (p < 0.001). Survival analysis demonstrated significantly faster healing in the NPWT group (log-rank test, p < 0.001). In the stratified multivariable Cox model adjusting for age, hemoglobin A1c, and sex, NPWT therapy remained independently associated with accelerated wound healing (adjusted hazard ratio 2.77, 95% confidence interval 1.40-5.47; p = 0.003).

Conclusion: Nurse-managed NPWT was associated with faster wound healing across SHID Stages 3-5. SHID-based severity assessment may provide useful prognostic information for interpreting healing trajectories, treatment planning, and follow-up monitoring.