Diabetic Foot Ulcer tPEARLNCT07099482
"Ultrasound-Enhanced Propolis Therapy for Healing Diabetic Foot Wounds"
A study testing Propolis gel (10%) in people with Diabetic Foot Ulcer t and Type 1 Diabetes Mellitus, run by Sinai University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcer t, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- What is being tested?
- Propolis gel (10%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 25 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 this study
Official title: Effectiveness of Propolis Phonophoresis on Wound Healing in Diabetic Ulcer: a Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Diabetic Foot Ulcer t, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Wound Management, Chronic Wound Healing
- Being tested
- Sham ultrasound (placebo), Propolis gel (10%)
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham ultrasound (placebo)Device
Also called Standard wound care procedures (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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: Sham ultrasound (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start30 Aug 2026 (estimated)
- Primary completion25 Aug 2027 (estimated)
- Study completion25 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer tStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, randomized, double-blind, controlled trial comparing propolis phonophoresis versus standard wound care.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Gomaa Atiaa, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099482
- Sponsor's protocol ID
- SU.REC.2025(47H)
- Acronym
- PEARL
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Propolis Phonophoresis on Wound Healing in Diabetic Ulcer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07099482
- Acronym / sponsor ID
- PEARL / SU.REC.2025(47H)
- Conditions
- Diabetic Foot Ulcer t, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Wound Management, Chronic Wound Healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 25 Aug 2027 (estimated)
- Study completion
- 25 Sep 2027 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Two-arm, randomized, double-blind, controlled trial comparing propolis phonophoresis versus standard wound care.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Propolis Phonophoresis | Experimental | Device: Sham ultrasound (placebo), Drug: Propolis gel (10%)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) |
| Standard Wound Care + Sham Ultrasound | Placebo comparator | 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. Interventions: * Other: Standard wound care procedures * Device: Sham ultrasound (placebo) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham ultrasound (placebo)Also: Standard wound care procedures (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. | Device | Experimental: Propolis Phonophoresis, Standard Wound Care + Sham Ultrasound |
| Propolis gel (10%)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. | Drug | Experimental: Propolis Phonophoresis |
Primary outcome
Percentage Reduction in Wound Area
Time frame: Baseline to Week 4
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Propolis gel (10%) in people with Diabetic Foot Ulcer t and Type 1 Diabetes Mellitus, run by Sinai University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Reduction in Wound Area (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.