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Search / Trial NCT07099482

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

Launched by SINAI UNIVERSITY · Jul 25, 2025

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help heal foot wounds in people with diabetes. These wounds, called diabetic foot ulcers, can be hard to heal and may cause serious problems. The study is testing whether using ultrasound waves can help a natural bee product called propolis get deeper into the skin to speed up healing. Propolis has properties that can reduce inflammation and fight infection, but it usually doesn’t absorb well on its own. By combining it with ultrasound therapy, researchers hope to see if this method works better than the usual wound care.

Adults between 18 and 75 years old who have type 1 or type 2 diabetes and a diabetic foot ulcer of a certain size may be eligible to join. To participate, the wound should be mild to moderate (not severely infected), and people should not have allergies to propolis or be pregnant or breastfeeding. Participants will be randomly assigned to receive either the propolis ultrasound treatment or standard care. The study will track how the wounds heal, how much pain is experienced, if infections occur, and overall quality of life. This trial is not yet recruiting, but if you or a loved one fits these criteria, it might be worth discussing with your doctor.

Gender

ALL

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

About Sinai University

Sinai University is a leading academic institution dedicated to advancing medical research and healthcare innovation. With a commitment to excellence in clinical trials, the university leverages its robust infrastructure and interdisciplinary collaboration to conduct cutting-edge studies that address critical health challenges. Sinai University aims to enhance patient outcomes through rigorous scientific inquiry, ethical research practices, and a focus on translating findings into practical applications in clinical settings. Its diverse team of experts is dedicated to fostering a culture of integrity, transparency, and community engagement in all research initiatives.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported