Diabetic Foot Ulcerulcer healingNCT06808191
Effect of Magnetic Current on Ulcer Healing
A study testing pulsed electromagnetic currant machine in people with Diabetic Foot Ulcer, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effectiveness of magnetic current in the management of DFUs as an alternative therapy on promoting the healing of chronic diabetic foot ulcers as compared with a control group.Twenty diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be… Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- pulsed electromagnetic currant machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Aug 2025
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. The ankle brachial index should fall between 0.9 and 1.2 to reassure that arterial insufficiency was not causing or contributing to the nonhealing wound.
- 2. Patients diagnosed with diabetes with unsatisfactory healing of ulcer(s) in the preceding 4 weeks.
- 3. Wagner grade 1 or 2 ulcers on the foot without exposure of bone, muscle, ligaments, or tendons.
Who cannot join
- 1- Ulcers secondary to non-diabetic etiology. 2- Poorly controlled diabetes. 3- Pregnancy. 4- Patients wearing a pacemaker or with malignancy or history of radiotherapy. 5- Patients who were taking medications that might affect their circulation or sensation and motor functioning and patients with any history of alcoholism were also excluded.
- 6- Patients who had clinical signs of infection or were taking antibiotics at the time of enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Beni-Suif University Hospital
Cairo, Cairo Governorate, 11865
mahmoud awd elkholy, lecturer, 00201125746573, elkholym774@gmail.com
mahmoud awd elkholy, lecturer, 0020115746573
About this study
Official title: Effect of Magnetic Current on Chronic Ulcer Healing of Diabetic Foot
This study aims to evaluate the effectiveness of magnetic current in the management of DFUs as an alternative therapy on promoting the healing of chronic diabetic foot ulcers as compared with a control group.Twenty diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group):
1- Group A: Pulsed electromagnetic field (PEMF) group. 2- Group B: Control group. Assessments of the healing of ulcers will be performed at the baseline, post-treatment evaluation (ie, after 14 treatment sessions), and 1-month follow-up.
:
Read the detailed description
This study aims to evaluate the effectiveness of magnetic current in the management of DFUs as an alternative therapy on promoting the healing of chronic diabetic foot ulcers as compared with a control group.Twenty diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group):
- Group A: Pulsed electromagnetic field (PEMF) group.
- Group B: Control group. Assessments of the healing of ulcers will be performed at the baseline, post-treatment evaluation (ie, after 14 treatment sessions), and 1-month follow-up.
Outcome measures will include:
- Wound closure.
- Wound depth.
- Microcirculation.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- pulsed electromagnetic currant machine, Placebo
- Keywords
- ulcer diabetic magnetic
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed electromagnetic currant machineDevice
Pulsed electromagnetic therapy will be delivered at the frequency of 12Hz, with magnetic flux density of 12G. Each treatment session will last for 1 hour, which will be repeated for 14 sessions within 4weeks.
PlaceboOther
control group will receive intervention by using the same PEMF unit, but the output will be shut off.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Pulsed electromagnetic therapy will be delivered at the frequency of 12Hz, with magnetic flux density of 12G. Each treatment session will last for 1 hour, which will be repeated for 14 sessions within 3weeks. 20 patients will remain in the study until the wound heals or 14 sessions will be completed, whichever came first Receives: Device: pulsed electromagnetic currant machine |
| Group B | Placebo comparator | 20 patients will receive intervention by using the same PEMF unit, but the output will be shut off. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ulcer size
smart phone applications used to calculate wound size
Measured: 4 weeks
Doppler ultrasonography
used to calculate wound depth and microcirculation angiogenesis
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Model description
- diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group): 1. Group A: Pulsed electromagnetic field (PEMF) group. 2. Group B: Control group.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Awad Ramadan Elkholy, Beni-Suef University
- Investigators
- heba mohamed ali, Professor of Physical therapy, Study chair, beni suif universitymahmoud awd elkholy, lecturer of physical therapy, Study director, beni suif universityasmaa ramadan kamel, physiotherapist, Principal investigator, beni suif university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808191
- Sponsor's protocol ID
- FMBSUREC/03032024/Kamel
- Acronym
- ulcer healing
- Status last verified
- Dec 2024
- First submitted
- 29 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: i dont know
Publications
Kwan RL, Cheing GL, Vong SK, Lo SK. Electrophysical therapy for managing diabetic foot ulcers: a systematic review. Int Wound J. 2013 Apr;10(2):121-31. doi: 10.1111/j.1742-481X.2012.01085.x. Epub 2012 Sep 7.
PubMed 22958779
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnetic Current on Chronic Ulcer Healing of Diabetic Foot
- ClinicalTrials.gov ID
- NCT06808191
- Acronym / sponsor ID
- ulcer healing / FMBSUREC/03032024/Kamel
- Conditions
- Diabetic Foot Ulcer
- Keywords
- ulcer diabetic magnetic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 5 Feb 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 the effectiveness of magnetic current in the management of DFUs as an alternative therapy on promoting the healing of chronic diabetic foot ulcers as compared with a control group.Twenty diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group):
1- Group A: Pulsed electromagnetic field (PEMF) group. 2- Group B: Control group. Assessments of the healing of ulcers will be performed at the baseline, post-treatment evaluation (ie, after 14 treatment sessions), and 1-month follow-up.
:
Detailed description
This study aims to evaluate the effectiveness of magnetic current in the management of DFUs as an alternative therapy on promoting the healing of chronic diabetic foot ulcers as compared with a control group.Twenty diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group):
- Group A: Pulsed electromagnetic field (PEMF) group.
- Group B: Control group. Assessments of the healing of ulcers will be performed at the baseline, post-treatment evaluation (ie, after 14 treatment sessions), and 1-month follow-up.
Outcome measures will include:
- Wound closure.
- Wound depth.
- Microcirculation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group): 1. Group A: Pulsed electromagnetic field (PEMF) group. 2. Group B: Control group.
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Device: pulsed electromagnetic currant machinePulsed electromagnetic therapy will be delivered at the frequency of 12Hz, with magnetic flux density of 12G. Each treatment session will last for 1 hour, which will be repeated for 14 sessions within 3weeks. 20 patients will remain in the study until the wound heals or 14 sessions will be completed, whichever came first |
| Group B | Placebo comparator | Other: Placebo20 patients will receive intervention by using the same PEMF unit, but the output will be shut off. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. The ankle brachial index should fall between 0.9 and 1.2 to reassure that arterial insufficiency was not causing or contributing to the nonhealing wound.
- 2. Patients diagnosed with diabetes with unsatisfactory healing of ulcer(s) in the preceding 4 weeks.
- 3. Wagner grade 1 or 2 ulcers on the foot without exposure of bone, muscle, ligaments, or tendons.
Key exclusion criteria (2 listed)
- 1- Ulcers secondary to non-diabetic etiology. 2- Poorly controlled diabetes. 3- Pregnancy. 4- Patients wearing a pacemaker or with malignancy or history of radiotherapy. 5- Patients who were taking medications that might affect their circulation or sensation and motor functioning and patients with any history of alcoholism were also excluded.
- 6- Patients who had clinical signs of infection or were taking antibiotics at the time of enrollment.
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 |
|---|---|---|
| pulsed electromagnetic currant machinePulsed electromagnetic therapy will be delivered at the frequency of 12Hz, with magnetic flux density of 12G. Each treatment session will last for 1 hour, which will be repeated for 14 sessions within 4weeks. | Device | group A |
| Placebocontrol group will receive intervention by using the same PEMF unit, but the output will be shut off. | Other | Group B |
Primary outcome
ulcer size
Time frame: 4 weeks
smart phone applications used to calculate wound size
Doppler ultrasonography
Time frame: 4 weeks
used to calculate wound depth and microcirculation angiogenesis
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 5 Feb 2025.
- Results publication: PubMed 22958779Kwan RL, Cheing GL, Vong SK, Lo SK. Electrophysical therapy for managing diabetic foot ulcers: a systematic review. Int Wound J. 2013 Apr;10(2):121-31. doi: 10.1111/j.1742-481X.2012.01085.x. Epub 2012 Sep 7.
- Individual participant dataSharing planned: Undecided. i dont know
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
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Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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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.
heba mohamed ali, Professor of Physical therapy study chair
beni suif university
mahmoud awd elkholy, lecturer of physical therapy study director
beni suif university
asmaa ramadan kamel, physiotherapist principal investigator
beni suif 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 pulsed electromagnetic currant machine in people with Diabetic Foot Ulcer, run by Beni-Suef 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 3 inclusion and 2 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 5 Feb 2025. 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. 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?
Contact Mahmoud awd elkholy, lecturer of physical therapy (00201125746573, elkholym774@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ulcer size (time frame: 4 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?
On the ClinicalTrials.gov record for NCT06808191, which also lists 1 linked publication.
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 5 Feb 2025.