Comparative Study of Negative-Pressure Wound Therapy Integrated With Silver Nanoparticle Spray Versus Negative-Pressure Wound Therapy in Post-Revascularization Diabetic Foot Wound Management

This was a prospective, parallel-group, randomized controlled trial conducted at the Vascular Surgery Department of Kafrelsheikh University Hospital, Egypt. The study was approved by the Institutional Review Board and conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants. Patients were eligible if they were ≥18 years of age, had diabetes mellitus with critical limb ischemia (CLI) classified as Rutherford category 6 or Fontaine stage IV, and presented with infected or ischemic foot wounds (Wagner grades 2-4) after successful revascularization confirmed by clinical and imaging evaluation. Exclusion criteria included osteomyelitis, active purulent discharge requiring further debridement, known allergy to silver or NPWT components, and inability to attend follow-up. A total of 100 patients were randomized into two equal groups using a computer-generated list with sealed opaque envelopes. Twelve patients were excluded post-randomization, resulting in 88 patients (44 per group) for final analysis. Group A received NPWT integrated with silver nanoparticle spray applied for 15 minutes before NPWT application using foam pre-soaked with the same spray. Group B received standard NPWT after saline irrigation. NPWT settings were -125 mmHg, continuous, with dressing changes every 72 hours. Primary outcome: time to complete epithelialization. Secondary outcomes: wound size reduction, CRP change, infection rate, pain (VAS), hospital stay, reintervention. Patients were followed weekly for 1 month and then biweekly for 6 months. CRP, WBC, wound measurements, and VAS were assessed at each visit. SPSS v26 was used for analysis. Shapiro-Wilk test for normality. Independent t-tests and Mann-Whitney U tests for continuous data. Chi-square or Fisher's exact test for categorical variables. Significance at p \< 0.05.

NCT Number	NCT07147790
Lead Sponsor	Kafrelsheikh University
Conditions	Ischemia Limb, Diabete Mellitus
Enrollment	100 participants
Start Date	2024-05-05
Primary Completion	2025-10-10 (estimated)
Study Completion	2025-12-10 (estimated)
Updated on ClinicalTrials.gov	2025-09-11