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Completed

NCT Number: NCT07821996

Effect of Silver Nanoparticles Phonophoresis on Diabetic Foot Ulcer Heeling

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

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active silver nanoparticle phonophoresis

Device

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 therapy

Device

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 Care

Other

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

Primary outcomes

  1. Ulcer Surface Area

    Time frame: 3 weeks

    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.

  2. Ulcer Volume Displacement Evaluation

    Time frame: 3 weeks

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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