Effect of Silver Nanoparticles Phonophoresis on Diabetic Foot Ulcer Heeling

N/ACompletedNCT07821996

Cairo University36 enrolled

Overview

This study was conducted to evaluate the effect of silver nanoparticle phonophoresis on accelerating chronic diabetic foot ulcer healing.

Silver nanoparticle phonophoresis enhances anti-inflammatory actions by reducing pro-inflammatory cytokines. The effectiveness of topical nanoparticles is constrained due to rapid inactivation by biological debris, making phonophoresis an optimal delivery method, which uses low-intensity ultrasound to penetrate deeply into tissues, enhancing permeability and accelerating healing. The study aimed to evaluate the effect of silver nanoparticle phonophoresis on improving healing in chronic diabetic foot ulcers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetic Foot Ulcer

Interventions

Active silver nanoparticle phonophoresisDEVICE

A nanosilver gel was directly introduced as the primary coupling interface. An ultrasound device was utilized at a low intensity of 0.5 W/cm², for 1 minute of active sonication per 1 cm² of ulcer size, 2 times per week for 3 weeks

Isolated low-intensity pulsed ultrasound therapyDEVICE

Patients received low-intensity pulsed ultrasound therapy utilizing standard, aqua-gel. After application of ultrasound, the wound bed was dried, and the silver nanoparticle gel was topically applied. It was applied for 2 times per week for 3 weeks.

Standard wound careOTHER

It included standard nursing care (daily dressing and debridement if needed)

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type1 or Type 2 Diabetes Mellitus with chronic foot ulcer. * Clear clinical documentation of superficial infection. Exclusion Criteria: * Deep bone osteomyelitis. * Peripheral gangrene. * Severe local ischemia. * Pregnancy. * Systemic multi-organ failure.

Locations (1)

Cairo university

Cairo, Egypt

Outcomes

Primary Outcomes

Ulcer Surface Area

It was calculated using digital planimetry. A calibration marker was positioned adjacent to the border. The camera of a smartphone having the validated IMITO Wound mobile application was maintained at a distance of 20-30 cm to record the photo and extract ulcer surface area.

Time frame: 3 weeks

Ulcer Volume Displacement Evaluation

It was evaluated by the sterile fluid-injection method. Sterile saline solution was injected into the ulcer cavity via a calibrated syringe. The volume of saline injected was measured to determine volumetric dimensions.

Time frame: 3 weeks

Data from ClinicalTrials.gov

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