"Ultrasound-Enhanced Propolis Therapy for Healing Diabetic Foot Wounds" (PEARL)

Sinai University

Status: Not yet enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07099482

SU.REC.2025(47H)

Details and patient eligibility

About

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.

Full description

This randomized, double-blind, controlled clinical trial investigates the therapeutic effectiveness of propolis phonophoresis in treating diabetic foot ulcers (DFUs). DFUs affect approximately 25% of diabetic patients and are associated with high morbidity, prolonged healing, and significant healthcare costs. Propolis, a resinous substance produced by honeybees, has shown antimicrobial, anti-inflammatory, and wound-healing properties in previous studies. However, its limited skin permeability reduces its clinical utility when used topically.

Phonophoresis is a non-invasive technique that uses ultrasound waves to enhance transdermal drug delivery. This study combines a 10% propolis gel with therapeutic ultrasound (1 MHz, 0.5-1.5 W/cm², pulsed mode at 20%) to evaluate its impact on wound healing outcomes compared to standard wound care. The intervention group will receive propolis phonophoresis therapy three times per week for four weeks. The control group will receive standard wound care and a sham ultrasound.

Primary outcome measures include the percentage reduction in wound area, assessed via digital planimetry. Secondary outcomes include time to full wound closure, pain scores, infection rates, and quality-of-life assessments. The study is designed to explore whether this combined therapeutic approach can offer a clinically superior and non-surgical treatment alternative for patients with chronic diabetic ulcers.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Experimental: Propolis Phonophoresis

Experimental group

Description:

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)

Treatment:

Drug: Propolis gel (10%)

Device: Sham ultrasound (placebo)

Standard Wound Care + Sham Ultrasound

Placebo Comparator group

Description:

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)

Treatment:

Device: Sham ultrasound (placebo)