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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSinai University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Experimental: Propolis PhonophoresisExperimental treatment 2 interventions
Group B: Standard Wound Care + Sham UltrasoundPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage Reduction in Wound Area

The primary outcome will be the percentage reduction in the surface area of the diabetic foot ulcer from baseline to the end of the 4-week treatment period. Wound size will be measured using digital planimetry based on standardized wound photographs.

Time frame
Baseline to Week 4

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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