Effect of Silver Nanoparticles Phonophoresis on Diabetic Foot Ulcer Heeling

NCT07821996 | Completed

• 1 other identifier: P.T.REC/012/004821
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 weeks

Study Arms (2)

Silver nanoparticle phonophoresis and standred care group

EXPERIMENTAL

The participants received silver nanoparticle phonophoresis in addition to standard care for 3 weeks.

Device: Active silver nanoparticle phonophoresis; Other: Standard wound care

Isolated therapeutic ultrasound and standard care group

ACTIVE COMPARATOR

The participants received therapeutic ultrasound followed by topical silver nanoparticles gel in addition to standard care for 3 weeks.

Device: Isolated low-intensity pulsed ultrasound therapy; Other: Standard wound care

Interventions

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

Silver nanoparticle phonophoresis and standred care group

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.

Isolated therapeutic ultrasound and standard care group

Standard wound care OTHER

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

Isolated therapeutic ultrasound and standard care group; Silver nanoparticle phonophoresis and standred care group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Type1 or Type 2 Diabetes Mellitus with chronic foot ulcer.
• Clear clinical documentation of superficial infection.

You may not qualify if:

• Deep bone osteomyelitis.
• Peripheral gangrene.
• Severe local ischemia.
• Pregnancy.
• Systemic multi-organ failure.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Officials

• Doaa A Aly

  Cairo University

  STUDY DIRECTOR

• Eman M Othman, As.professor

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: April 5, 2025
• Primary Completion: April 10, 2026
• Study Completion: April 20, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

EG (1)