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

NCT ID: NCT07147790

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-05
• Study Completion Date: 2025-12-10

Brief Summary

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.

Conditions

Ischemia Limb; Diabete Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

two groups A and B groups

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.

After successful revacularization, We will categorize patients into two groups : groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the woun

Intervention Type: DRUG

After successful revacularization, We will categorize patients into two groups :

groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the wound with silver nanoparticle spray for 15 minutes (time needed for its absorption) before applying NPWT with foam soaked in silver nanoparticle spray) and group B (The patient's wounds will be cleaned and irrigated with a normal saline solution for 15 minutes before applying NPWT.). Standard NPWT setting will be used in both groups, with a continuous negative pressure range from 70 to 125 mmHg. Selection criteria for the application of VAC therapy will be presented by calcaneal, dorsal, or plantar foot ulcers with an area of 4.0 and 10.2 cm2. The NPWT dressing will be changed every 3 days. The endpoint of NPWT will be the appearance of healthy granulation tissue.

Silver Nanoparticles Irrigant

Intervention Type: DRUG

After successful revacularization, We will categorize patients into two groups :

groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the wound with silver nanoparticle spray for 15 minutes (time needed for its absorption) before applying NPWT with foam soaked in silver nanoparticle spray) and group B (The patient's wounds will be cleaned and irrigated with a normal saline solution for 15 minutes before applying NPWT.). Standard NPWT setting will be used in both groups, with a continuous negative pressure range from 70 to 125 mmHg. Selection criteria for the application of VAC therapy will be presented by calcaneal, dorsal, or plantar foot ulcers with an area of 4.0 and 10.2 cm2. The NPWT dressing will be changed every 3 days. The endpoint of NPWT will be the appearance of healthy granulation tissue.

Interventions

After successful revacularization, We will categorize patients into two groups : groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the woun

After successful revacularization, We will categorize patients into two groups :

groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the wound with silver nanoparticle spray for 15 minutes (time needed for its absorption) before applying NPWT with foam soaked in silver nanoparticle spray) and group B (The patient's wounds will be cleaned and irrigated with a normal saline solution for 15 minutes before applying NPWT.). Standard NPWT setting will be used in both groups, with a continuous negative pressure range from 70 to 125 mmHg. Selection criteria for the application of VAC therapy will be presented by calcaneal, dorsal, or plantar foot ulcers with an area of 4.0 and 10.2 cm2. The NPWT dressing will be changed every 3 days. The endpoint of NPWT will be the appearance of healthy granulation tissue.

Intervention Type: DRUG

Silver Nanoparticles Irrigant

After successful revacularization, We will categorize patients into two groups :

groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the wound with silver nanoparticle spray for 15 minutes (time needed for its absorption) before applying NPWT with foam soaked in silver nanoparticle spray) and group B (The patient's wounds will be cleaned and irrigated with a normal saline solution for 15 minutes before applying NPWT.). Standard NPWT setting will be used in both groups, with a continuous negative pressure range from 70 to 125 mmHg. Selection criteria for the application of VAC therapy will be presented by calcaneal, dorsal, or plantar foot ulcers with an area of 4.0 and 10.2 cm2. The NPWT dressing will be changed every 3 days. The endpoint of NPWT will be the appearance of healthy granulation tissue.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient with critical limb ischemia(CLI) Rutherford stage 6 or Fontaine stage 4. Wounds classified as Wagner classification grade 2 to 4.Successful revascularization was confirmed by imaging and clinical assessment.

Exclusion Criteria

• 1. Patients with active infection(pus discharge and still need debridement), osteomyelitis.

2. patients who are allergic to silver or any components used in NPWT. 3. patients who are unable to follow up with us. patient

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Mohab Mohamed Abdelfattah Saeed

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kafr El Shaykh University

Kafr ash Shaykh, Kafrelshaykh Governorate, Egypt

Countries

Egypt

Other Identifiers

medical_research@kfs.edu.eg

Identifier Type: OTHER

Identifier Source: secondary_id

KFSIRB200-252

Identifier Type: -

Identifier Source: org_study_id