Diabetes MellitusNCT07070544
Effect of Electromagnetic Field Therapy and Customized Foot Insole on Peripheral Circulation and Ankle-Brachial Pressure Index in Patients With Diabetic Foot Ulcer
A study testing Electromagnetic Field Therapy: • Frequency: 50 Hz • Intensity: 5-30 mT • Duration: 30 minutes/session • Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: • Individually tailored based on in people with Diabetes Mellitus and Diabetic Foot Ulcer, run by South Valley University.
Trial summary
Diabetic foot ulcers (DFUs) are a significant complication of diabetes mellitus, associated with poor peripheral circulation, neuropathy, and increased risk of lower-limb amputation. Optimizing peripheral blood flow is critical in the prevention and management of DFUs. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Diabetic Foot Ulcer
- What is being tested?
- Electromagnetic Field Therapy: • Frequency: 50 Hz • Intensity: 5-30 mT • Duration: 30 minutes/session • Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: • Individually tailored based on
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Jan 2026
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Diagnosed with Type 2 Diabetes Mellitus.
- Presence of unilateral or bilateral diabetic foot ulcer.
- ABPI between 0.6 - 1.0 (mild to moderate arterial insufficiency).
Who cannot join
- • Severe peripheral arterial disease (ABPI <0.5).
- Active infection requiring hospitalization.
- History of amputation.
- Cardiac pacemaker or contraindication to EMF therapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Head of Department of Physical Therapy for Cardiovascular/Respiratory Disorders and Geriatrics
Diabetic foot ulcers (DFUs) are a significant complication of diabetes mellitus, associated with poor peripheral circulation, neuropathy, and increased risk of lower-limb amputation. Optimizing peripheral blood flow is critical in the prevention and management of DFUs. Traditional offloading strategies, such as customized foot insoles, have demonstrated efficacy in reducing plantar pressure and promoting ulcer healing.
Electromagnetic field (EMF) therapy is a non-invasive modality that has shown potential in enhancing microcirculation, promoting angiogenesis, and modulating inflammatory processes. Preliminary studies have suggested that EMF may improve peripheral circulation and tissue oxygenation in diabetic patients.
This study aims to investigate the combined effect of EMF therapy and customized foot insoles on peripheral circulation and Ankle-Brachial Pressure Index (ABPI) in patients with diabetic foot ulcers, hypothesizing that this integrated approach may yield superior outcomes compared to standard care.
Read the detailed description
- Objectives
Primary Objective:
- To evaluate the effect of EMF therapy combined with customized foot insoles on peripheral circulation in patients with diabetic foot ulcers.
Secondary Objective:
- To assess changes in Ankle-Brachial Pressure Index (ABPI) following intervention.
- To compare the ulcer healing rates and pain levels between intervention and control groups.
- Research Questions
- Does the combination of EMF therapy and customized foot insoles improve peripheral circulation in patients with diabetic foot ulcers?
- Is there a significant improvement in ABPI in the intervention group compared to control?
- What is the effect of the intervention on ulcer healing rates and pain reduction? ________________________________________
- Hypotheses
- H1: EMF therapy combined with customized foot insoles significantly improves peripheral circulation compared to standard care.
- H2: EMF therapy combined with customized foot insoles significantly improves ABPI in patients with diabetic foot ulcers.
- Conditions
- Diabetes Mellitus, Diabetic Foot Ulcer
- Being tested
- Electromagnetic Field Therapy: • Frequency: 50 Hz • Intensity: 5-30 mT • Duration: 30 minutes/session • Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: • Individually tailored based on
- Keywords
- Effect of Electromagnetic Field Therapy, Customized Foot Insole, Peripheral Circulation, Ankle-Brachial Pressure Index
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic Field Therapy: • Frequency: 50 Hz • Intensity: 5-30 mT • Duration: 30 minutes/session • Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: • Individually tailored based onDevice
Electromagnetic Field Therapy:
- Frequency: 50 Hz
- Intensity: 5-30 mT
- Duration: 30 minutes/session
- Frequency: 3 sessions/week for 8 weeks
Customized Foot Insoles:
- Individually tailored based on foot pressure mapping and deformity.
- Designed to offload pressure points and support foot arches.
Standard Care:
- Wound care, glycemic control, and patient education as per institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| The study Group | Active comparator | Electromagnetic Field Therapy:
* Frequency: 50 Hz
* Intensity: 5-30 mT
* Duration: 30 minutes/session
* Frequency: 3 sessions/week for 8 weeks
Customized Foot Insoles:
* Individually tailored based on foot pressure mapping and deformity.
* Designed to offload pressure points and support foot arches.
Standard Care:
• Wound care, glycemic control, and patient education as per institutional protocol. Receives: Device: Electromagnetic Field Therapy: • Frequency: 50 Hz • Intensity: 5-30 mT • Duration: 30 minutes/session • Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: • Individually tailored based on |
| The control group | Placebo comparator | Standard Care:
• Wound care, glycemic control, and patient education as per institutional protocol. Receives: Device: Electromagnetic Field Therapy: • Frequency: 50 Hz • Intensity: 5-30 mT • Duration: 30 minutes/session • Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: • Individually tailored based on |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow
Primary Outcome:
- Peripheral Circulation: Assessed by Laser Doppler Flowmetry and/or skin perfusion pressure (SPP).
Measured: Measurement Timeline: • Minimum value (Baseline)(Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)
Secondary outcomes (3)
• Ankle-Brachial Pressure Index (ABPI)
- Ankle-Brachial Pressure Index (ABPI): Measured using handheld Doppler.
Measured: Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)
• Ulcer Healing Rate
- Ulcer Healing Rate: Monitored through ulcer size reduction (planimetric tracing and digital photography).
Measured: Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)
• Pain Level:
- Pain Level: Measured using the Visual Analog Scale (VAS).
Measured: Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (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 Diabetes MellitusStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Abuzaid, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070544
- Sponsor's protocol ID
- South Valley University PTh
- Status last verified
- Jul 2025
- First submitted
- 8 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Burhan A, Arofiati F, Da Silva VA, Sebayang SM. Effect of Ankle Brachial Index (ABI) and Compression Therapy on Diabetic Foot Ulcer Healing. Curr Diabetes Rev. 2024;20(1):e310323215277. doi: 10.2174/1573399819666230331083420.
PubMed 37005544
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head of Department of Physical Therapy for Cardiovascular/Respiratory Disorders and Geriatrics
- ClinicalTrials.gov ID
- NCT07070544
- Acronym / sponsor ID
- South Valley University PTh
- Conditions
- Diabetes Mellitus, Diabetic Foot Ulcer
- Keywords
- Effect of Electromagnetic Field Therapy, Customized Foot Insole, Peripheral Circulation, Ankle-Brachial Pressure Index
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 17 Jul 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.
Diabetic foot ulcers (DFUs) are a significant complication of diabetes mellitus, associated with poor peripheral circulation, neuropathy, and increased risk of lower-limb amputation. Optimizing peripheral blood flow is critical in the prevention and management of DFUs. Traditional offloading strategies, such as customized foot insoles, have demonstrated efficacy in reducing plantar pressure and promoting ulcer healing.
Electromagnetic field (EMF) therapy is a non-invasive modality that has shown potential in enhancing microcirculation, promoting angiogenesis, and modulating inflammatory processes. Preliminary studies have suggested that EMF may improve peripheral circulation and tissue oxygenation in diabetic patients.
This study aims to investigate the combined effect of EMF therapy and customized foot insoles on peripheral circulation and Ankle-Brachial Pressure Index (ABPI) in patients with diabetic foot ulcers, hypothesizing that this integrated approach may yield superior outcomes compared to standard care.
Detailed description
- Objectives
Primary Objective:
- To evaluate the effect of EMF therapy combined with customized foot insoles on peripheral circulation in patients with diabetic foot ulcers.
Secondary Objective:
- To assess changes in Ankle-Brachial Pressure Index (ABPI) following intervention.
- To compare the ulcer healing rates and pain levels between intervention and control groups.
- Research Questions
- Does the combination of EMF therapy and customized foot insoles improve peripheral circulation in patients with diabetic foot ulcers?
- Is there a significant improvement in ABPI in the intervention group compared to control?
- What is the effect of the intervention on ulcer healing rates and pain reduction? ________________________________________
- Hypotheses
- H1: EMF therapy combined with customized foot insoles significantly improves peripheral circulation compared to standard care.
- H2: EMF therapy combined with customized foot insoles significantly improves ABPI in patients with diabetic foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The study Group | Active comparator | Device: Electromagnetic Field Therapy: • Frequency: 50 Hz • Intensity: 5-30 mT • Duration: 30 minutes/session • Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: • Individually tailored based onElectromagnetic Field Therapy: * Frequency: 50 Hz * Intensity: 5-30 mT * Duration: 30 minutes/session * Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: * Individually tailored based on foot pressure mapping and deformity. * Designed to offload pressure points and support foot arches. Standard Care: • Wound care, glycemic control, and patient education as per institutional protocol. |
| The control group | Placebo comparator | Device: Electromagnetic Field Therapy: • Frequency: 50 Hz • Intensity: 5-30 mT • Duration: 30 minutes/session • Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: • Individually tailored based onStandard Care: • Wound care, glycemic control, and patient education as per institutional protocol. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Diagnosed with Type 2 Diabetes Mellitus.
Key exclusion criteria (4 listed)
- • Severe peripheral arterial disease (ABPI <0.5).
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 |
|---|---|---|
| Electromagnetic Field Therapy: • Frequency: 50 Hz • Intensity: 5-30 mT • Duration: 30 minutes/session • Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: • Individually tailored based onElectromagnetic Field Therapy: * Frequency: 50 Hz * Intensity: 5-30 mT * Duration: 30 minutes/session * Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: * Individually tailored based on foot pressure mapping and deformity. * Designed to offload pressure points and support foot arches. Standard Care: • Wound care, glycemic control, and patient education as per institutional protocol. | Device | The control group, The study Group |
Primary outcome
Blood flow
Time frame: Measurement Timeline: • Minimum value (Baseline)(Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)
Primary Outcome: • Peripheral Circulation: Assessed by Laser Doppler Flowmetry and/or skin perfusion pressure (SPP).
3 secondary outcomes
• Ankle-Brachial Pressure Index (ABPI)
Time frame: Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)
• Ulcer Healing Rate
Time frame: Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)
• Pain Level:
Time frame: Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)
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 17 Jul 2025.
- Background: PubMed 37005544Burhan A, Arofiati F, Da Silva VA, Sebayang SM. Effect of Ankle Brachial Index (ABI) and Compression Therapy on Diabetic Foot Ulcer Healing. Curr Diabetes Rev. 2024;20(1):e310323215277. doi: 10.2174/1573399819666230331083420.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic Field Therapy: • Frequency: 50 Hz • Intensity: 5-30 mT • Duration: 30 minutes/session • Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: • Individually tailored based on in people with Diabetes Mellitus and Diabetic Foot Ulcer, run by South Valley 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 3 inclusion and 4 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 17 Jul 2025. 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?
Contact ibrahim ismail Abuzaid, PhD (+962777956592 ext. +201006512150, ibrahim_ismail_2011@svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow (time frame: Measurement Timeline: • Minimum value (Baseline)(Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)). 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 NCT07070544, 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 17 Jul 2025.