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NCT07099482
"Ultrasound-Enhanced Propolis Therapy for Healing Diabetic Foot Wounds"
Conditions: Diabetic Foot Ulcer t, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Wound Management, Chronic Wound Healing
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Sinai University
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07099482). StuddyBuddy aggregates publicly available trial information.