Abstract:

Objective To evaluate the efficacy of combining single-use negative pressure wound therapy （sNPWT） with ultrasound debridement （UD） for the treatment of diabetic foot ulcers （DFU） in an outpatient setting. Methods Sixty diabetic foot patients admitted to the Endocrinology and Metabolic Diseases Department of Shandong Second Medical University Affiliated Hospital between June 1， 2024， and June 30， 2025， were enrolled. Based on the actual treatment recorded in their medical records， they were divided into three groups （n = 20）： conventional therapy group （control group 1）， sNPWT group （control group 2）， and combined UD + sNPWT group （experimental group）. All patients received standard hypoglycemic and anti-infective therapy. Control group 1 received traditional surgical debridement with routine dressing changes. Control group 2 received traditional surgical debridement plus sNPWT. The experimental group received UD combined with sNPWT. The primary efficacy endpoints （wound area reduction rate， change in sinus tract depth， ulcer healing rate） and secondary endpoints （pain score， quality of life， C-reactive protein levels） were assessed among the three groups at 1， 2， and 4 weeks after treatment initiation. Results Primary efficacy endpoints： After 4 weeks， the wound reduction rate in the experimental group （69.16 ± 2.33） % was significantly higher than that in control group 1 （53.33 ± 2.27） % and control group 2 （58.47 ± 2.15） % （P < 0.05）. The sinus tract depth in the experimental group decreased to （0.47 ± 0.19） cm， significantly shallower than that in control group 1 ［（0.88 ± 0.40） cm］ and control group 2 ［（0.69 ± 0.32） cm］ （P < 0.05）. The overall clinical efficacy rate was 95.0% in both the experimental group and control group 2， significantly higher than the 65.0% in control group 1 （P < 0.05）. Secondary endpoints： The experimental group exhibited the lowest VAS pain score （2.05 points） and Wound-QoL score （26.65 points） among all groups （both P < 0.05）. Quality of life improvements were significantly greater than in control group 2 from week 2 onward （P < 0.05）. The C-reactive protein level in the experimental group ［（2.45 ± 0.36） mg/L］ at 4 weeks was significantly lower than that in control group 1 ［（2.86 ± 0.51） mg/L］ （P < 0.05）. Conclusion The combination of sNPWT and UD， applied for the first time in an outpatient setting for diabetic foot treatment， promotes wound healing， reduces pain， improves quality of life， and suppresses inflammatory factors in patients with DFU.

Key words: diabetic foot ulcer, negative pressure wound therapy, ultrasonic debridement