"Ultrasound-Enhanced Propolis Therapy for Healing Diabetic Foot Wounds"

Sponsor
Sinai University
Study ID
NCT07099482
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Sham ultrasound (placebo) — DEVICE
    Participants will receive conventional wound care including debridement, cleaning, and dressing. A sham ultrasound device that emits no therapeutic waves will be applied to simulate the intervention procedure.
  • Propolis gel (10%) — DRUG
    Participants will receive topical application of 10% propolis gel on the diabetic foot ulcer followed by therapeutic ultrasound (phonophoresis) using 1 MHz frequency, 0.5-1.5 W/cm² intensity, pulsed mode (20%), for 5 minutes per session, 3 sessions/week for 4 weeks.

Study Details

This study aims to evaluate whether using ultrasound (phonophoresis) can help deliver propolis-a natural compound made by bees-more effectively into the skin to speed up wound healing in people with diabetic foot ulcers. Diabetic foot ulcers are a common and serious complication of diabetes and often take a long time to heal. Propolis has natural anti-inflammatory and antimicrobial properties that may promote healing, but it does not easily penetrate the skin. By using ultrasound to enhance absorption, this study tests whether combining propolis with phonophoresis is more effective than standard wound care alone. Participants will be randomly assigned to receive either the propolis ultrasound therapy or standard care. The study will measure wound size, healing time, pain, infection rates, and quality of life.

Key Dates

First listed
Aug 1, 2025
Start date
May 30, 2026
Status verified
May 2026
Primary completion
Aug 25, 2026
Completion
Sep 25, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Propolis Phonophoresis
    Participants will receive topical application of 10% propolis gel on the diabetic foot ulcer followed by therapeutic ultrasound (phonophoresis) using 1 MHz frequency, 0.5-1.5 W/cm² intensity, pulsed mode (20%), for 5 minutes per session, 3 sessions/week for 4 weeks .Interventions: * Drug: Propolis gel (10%) * Device: Therapeutic ultrasound (phonophoresis)
  • Placebo Comparator: Standard Wound Care + Sham Ultrasound
    Participants will receive conventional wound care including debridement, cleaning, and dressing. A sham ultrasound device that emits no therapeutic waves will be applied to simulate the intervention procedure. Interventions: * Other: Standard wound care procedures * Device: Sham ultrasound (placebo)

Primary Outcome Measure

Percentage Reduction in Wound Area [ Time Frame: Baseline to Week 4 ]

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