Diabetic Foot UlcerNCT07821996
Effect of Silver Nanoparticles Phonophoresis on Diabetic Foot Ulcer Heeling
A study testing Active silver nanoparticle phonophoresis, Isolated low-intensity pulsed ultrasound therapy and Standard wound care in people with Diabetic Foot Ulcer, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to evaluate the effect of silver nanoparticle phonophoresis on accelerating chronic diabetic foot ulcer healing. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Active silver nanoparticle phonophoresis, Isolated low-intensity pulsed ultrasound therapy and Standard wound care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2025to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type1 or Type 2 Diabetes Mellitus with chronic foot ulcer.
- Clear clinical documentation of superficial infection.
Who cannot join
- Deep bone osteomyelitis.
- Peripheral gangrene.
- Severe local ischemia.
- Pregnancy.
- Systemic multi-organ failure.
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted to evaluate the effect of silver nanoparticle phonophoresis on accelerating chronic diabetic foot ulcer healing.
Read the detailed description
Silver nanoparticle phonophoresis enhances anti-inflammatory actions by reducing pro-inflammatory cytokines. The effectiveness of topical nanoparticles is constrained due to rapid inactivation by biological debris, making phonophoresis an optimal delivery method, which uses low-intensity ultrasound to penetrate deeply into tissues, enhancing permeability and accelerating healing. The study aimed to evaluate the effect of silver nanoparticle phonophoresis on improving healing in chronic diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Active silver nanoparticle phonophoresis, Isolated low-intensity pulsed ultrasound therapy, Standard wound care
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active silver nanoparticle phonophoresisDevice
A nanosilver gel was directly introduced as the primary coupling interface. An ultrasound device was utilized at a low intensity of 0.5 W/cm², for 1 minute of active sonication per 1 cm² of ulcer size, 2 times per week for 3 weeks
Isolated low-intensity pulsed ultrasound therapyDevice
Patients received low-intensity pulsed ultrasound therapy utilizing standard, aqua-gel. After application of ultrasound, the wound bed was dried, and the silver nanoparticle gel was topically applied. It was applied for 2 times per week for 3 weeks.
Standard wound careOther
It included standard nursing care (daily dressing and debridement if needed)
| Study group | Role | What they receive |
|---|---|---|
| Silver nanoparticle phonophoresis and standred care group | Experimental | The participants received silver nanoparticle phonophoresis in addition to standard care for 3 weeks. Receives: Device: Active silver nanoparticle phonophoresis; Other: Standard wound care |
| Isolated therapeutic ultrasound and standard care group | Active comparator | The participants received therapeutic ultrasound followed by topical silver nanoparticles gel in addition to standard care for 3 weeks. Receives: Device: Isolated low-intensity pulsed ultrasound therapy; Other: Standard wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer Surface Area
It was calculated using digital planimetry. A calibration marker was positioned adjacent to the border. The camera of a smartphone having the validated IMITO Wound mobile application was maintained at a distance of 20-30 cm to record the photo and extract ulcer surface area.
Measured: 3 weeks
Ulcer Volume Displacement Evaluation
It was evaluated by the sterile fluid-injection method. Sterile saline solution was injected into the ulcer cavity via a calibrated syringe. The volume of saline injected was measured to determine volumetric dimensions.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start5 Apr 2025
- Primary completion10 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohammed Hussein, Cairo University
- Investigators
- Doaa A Aly, Study director, Cairo UniversityEman M Othman, As.professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821996
- Sponsor's protocol ID
- P.T.REC/012/004821
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Silver Nanoparticles Phonophoresis on Diabetic Foot Ulcer Heeling
- ClinicalTrials.gov ID
- NCT07821996
- Acronym / sponsor ID
- P.T.REC/012/004821
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Apr 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 16 Sep 2026 (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 was conducted to evaluate the effect of silver nanoparticle phonophoresis on accelerating chronic diabetic foot ulcer healing.
Detailed description
Silver nanoparticle phonophoresis enhances anti-inflammatory actions by reducing pro-inflammatory cytokines. The effectiveness of topical nanoparticles is constrained due to rapid inactivation by biological debris, making phonophoresis an optimal delivery method, which uses low-intensity ultrasound to penetrate deeply into tissues, enhancing permeability and accelerating healing. The study aimed to evaluate the effect of silver nanoparticle phonophoresis on improving healing in chronic diabetic foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver nanoparticle phonophoresis and standred care group | Experimental | Device: Active silver nanoparticle phonophoresis, Other: Standard wound careThe participants received silver nanoparticle phonophoresis in addition to standard care for 3 weeks. |
| Isolated therapeutic ultrasound and standard care group | Active comparator | Device: Isolated low-intensity pulsed ultrasound therapy, Other: Standard wound careThe participants received therapeutic ultrasound followed by topical silver nanoparticles gel in addition to standard care for 3 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Type1 or Type 2 Diabetes Mellitus with chronic foot ulcer.
- Clear clinical documentation of superficial infection.
Key exclusion criteria (5 listed)
- Deep bone osteomyelitis.
- Peripheral gangrene.
- Severe local ischemia.
- Pregnancy.
- Systemic multi-organ failure.
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 |
|---|---|---|
| Active silver nanoparticle phonophoresisA nanosilver gel was directly introduced as the primary coupling interface. An ultrasound device was utilized at a low intensity of 0.5 W/cm², for 1 minute of active sonication per 1 cm² of ulcer size, 2 times per week for 3 weeks | Device | Silver nanoparticle phonophoresis and standred care group |
| Isolated low-intensity pulsed ultrasound therapyPatients received low-intensity pulsed ultrasound therapy utilizing standard, aqua-gel. After application of ultrasound, the wound bed was dried, and the silver nanoparticle gel was topically applied. It was applied for 2 times per week for 3 weeks. | Device | Isolated therapeutic ultrasound and standard care group |
| Standard wound careIt included standard nursing care (daily dressing and debridement if needed) | Other | Isolated therapeutic ultrasound and standard care group, Silver nanoparticle phonophoresis and standred care group |
Primary outcome
Ulcer Surface Area
Time frame: 3 weeks
It was calculated using digital planimetry. A calibration marker was positioned adjacent to the border. The camera of a smartphone having the validated IMITO Wound mobile application was maintained at a distance of 20-30 cm to record the photo and extract ulcer surface area.
Ulcer Volume Displacement Evaluation
Time frame: 3 weeks
It was evaluated by the sterile fluid-injection method. Sterile saline solution was injected into the ulcer cavity via a calibrated syringe. The volume of saline injected was measured to determine volumetric dimensions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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. This study is not recruiting at the moment.
Doaa A Aly study director
Cairo University
Eman M Othman, As.professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active silver nanoparticle phonophoresis, Isolated low-intensity pulsed ultrasound therapy and Standard wound care in people with Diabetic Foot Ulcer, run by Cairo University at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ulcer Surface Area (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 16 Sep 2026.