An interventional study of Sham ultrasound (placebo) and Propolis gel (10%) in Diabetic Foot Ulcer t, Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, sponsored by Sinai University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Sinai University · Not applicable, Interventional, and Treatment
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.
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 80 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
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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
Exclusion Criteria:
Severe infection or presence of osteomyelitis at the ulcer site
Use of systemic or
Known allergy or to propolis
Pregnant or breastfeeding women
Participation in another clinical trial within the past 30 days
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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%)
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)
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)
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.
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Propolis
Sinai University