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

NCT07099482 | Not Yet Recruiting

• 1 other identifier: SU.REC.2025(47H)
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetic Foot Ulcer t; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus; Wound Management; Chronic Wound Healing

Outcome Measures

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.

  Baseline to Week 4

Study Arms (2)

Experimental: Propolis Phonophoresis

EXPERIMENTAL

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)

Device: Sham ultrasound (placebo); Drug: Propolis gel (10%)

Standard Wound Care + Sham Ultrasound

PLACEBO COMPARATOR

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)

Device: Sham ultrasound (placebo)

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.

Also known as: Standard wound care procedures (placebo)

Experimental: Propolis Phonophoresis; Standard Wound Care + Sham Ultrasound

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.

Experimental: Propolis Phonophoresis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 75 years
• Diagnosed with type 1 or type 2 diabetes mellitus
• Presence of a diabetic foot ulcer classified as Grade 1 or 2 (Wagner classification)
• Ulcer size between 1 cm² and 5 cm²
• Able and willing to provide informed consent

You may not qualify if:

• Severe infection or presence of osteomyelitis at the ulcer site
• Use of systemic immunosuppressants or corticosteroids
• Known allergy or hypersensitivity to propolis
• Pregnant or breastfeeding women
• Participation in another clinical trial within the past 30 days

Sponsors & Collaborators

• Sinai University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants in both groups receive what appears to be the same treatment procedure. The intervention group receives active ultrasound therapy, while the control group receives a sham (non-therapeutic) ultrasound, keeping both participants and care providers blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Two-arm, randomized, double-blind, controlled trial comparing propolis phonophoresis versus standard wound care.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05