Peripheral Arterial Disease (PAD)NCT07864805
Electromagnetic Therapy, Peripheral Vascular Diseases, Diabetes
A study testing Low-frequency pulsed electromagnetic therapy plus interval exercise training program in people with Peripheral Arterial Disease (PAD) and Diabete Type 2, run by Ashraf Abdelaal at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial was to investigate the efficacy of Low frequency pulsed electromagnetic therapy (LFPEMT) in improving vascular-related quality of life (VQ) and spatiotemporal gait parameters in individuals with Type 2 Diabetes mellitus (T2DM) and Peripheral arterial disease (PAD). Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Peripheral Arterial Disease (PAD), Diabete Type 2, Gait Abnormality
- What is being tested?
- Low-frequency pulsed electromagnetic therapy plus interval exercise training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jul 2025to 28 May 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 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 60-70 years
- Medically controlled T2DM for more than 5 years, treated with oral antidiabetic medications only.
- Glycated haemoglobin (HbA1c) levels >6.5% and ≤11%.
- Established diagnosis of PAD Stage I and IIa or Rutherford stage 0 and 1.
- Mild peripheral arterial obstruction (0.7< ABI<0.9).
- Medically controlled blood pressure and sedentary life style.
- Body mass index (BMI)<30 kg/m2; and and adequate cognitive function.
Who cannot join
- 60<age<70 years.
- Insulin therapy.
- Recent infectious or serious cardiopulmonary or neuromusculoskeletal conditions that could compromise participant safety or affect the accuracy of study outcomes.
- Implanted electronic devices.
- Uncontrolled blood pressure.
- Participation in any structured dietary or exercise programs within the last 6 months.
- Refusal to provide written informed consent for participation in the study and publication of its results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Electromagnetic Field Therapy on Improving Quality of Life and Gait Performance in Patients With Type 2 Diabetes Mellitus and Peripheral Arterial Disease. Randomized Controlled Trial
The goal of this clinical trial was to investigate the efficacy of Low frequency pulsed electromagnetic therapy (LFPEMT) in improving vascular-related quality of life (VQ) and spatiotemporal gait parameters in individuals with Type 2 Diabetes mellitus (T2DM) and Peripheral arterial disease (PAD).
The main questions it aimed to answer are:
Read more
- Is the LFPEMT effective in improving VQ in patients with T2DM and PAD?
- Is the LFPEMT effective in improving spatiotemporal gait parameters in patients with T2DM and PAD? Researchers compared group A (received LFPEMT plus interval exercise training program) to group B (received placebo LFPEMT plus the same interval exercise training program) to see if LFPEMT is effective in improving gait parameters and vascular related quality of life in patients with T2DM and PAD.
Participants in group A received LFPEMT plus moderate intensity interval training, while participants in group B received placebo LFPEMT plus the same moderate intensity interval training.
Read the detailed description
Peripheral arterial disease (PAD) is a common diabetes-related complication characterized by narrowing or occlusion of the peripheral arteries [2], most commonly those supplying the lower limbs. This vascular impairment reduces blood flow and predisposes tissues to ischemia and death. Type 2 Diabetes mellitus (T2DM) is a major risk factor for PAD through multidimensional pathogenic pathways, including T2DM-related inflammation, platelet aggregation, and endothelial and vascular smooth muscle dysfunction.
Peripheral arterial disease negatively impacts patient's life that progressively deteriorates as the PAD progress, presented with intermittent claudication, weak peripheral pulse, delayed or non-healing wounds, skin discoloration and cold extremities.
The association between T2DM and PAD has received increasing attention over the past several years. T2DM increases the risk of PAD by two to four times compared with individuals without T2DM. The prevalence of PAD is approximately 20-50% among older adults with diabetes mellitus (DM), and about 12.5-22% among older adults with T2DM. Approximately 15% of patients with DM develop PAD within 10 years, and this ratio increases to 45% after 20 years.
Health-related quality of life (HRQOL) is increasingly recognized as an important indicator for overall health status. Individuals with long-standing T2DM experience deteriorations across physical, psychological, social, and environmental domains of HRQOL. Furthermore, diabetes-related PAD is associated with significantly reduced quality of life, impaired gait performance, and decreased mobility function in older adults. Effective management of PAD is therefore a key factor in improving HRQOL among individuals with DM.
Effective PAD management programs have become an important public health priority, highlighting the need to implement safe, effective, and evidence-based treatment strategies to optimize clinical outcomes and prevent complications in individuals with DM and PAD. Exercise training is an important component of PAD rehabilitation programs because of its established efficacy in increasing walking distance and improving quality of life, reducing cardiovascular disease risk, and enhancing functional performance in individuals with PAD.
Low frequency pulsed electromagnetic therapy (LFPEMT) is a safe, noninvasive therapeutic modality that is commonly used in the management of individuals with T2DM. It has also become an important preventive and therapeutic component of comprehensive management program for individuals with T2DM and PAD. LFPEMT has been reported to improve arterial blood flow in individuals with T2DM and PAD. Incorporating the LFPEMT into T2DM management programs may favorably modulate cardiovascular disease risk, reduce peripheral arterial disease severity, and improve functional outcomes in individuals with T2DM. LFPEMT acts noninvasively to produce neurostimulatory, vasoactive, and analgesic effects, thereby favorably modulating various metabolic, cardiovascular, musculoskeletal, and functional variables in individuals with T2DM.
Despite its favorable effects and wide range of applications, important knowledge gaps remain regarding the efficacy of LFPEMFT in improving vascular-related quality of life (VQ) and spatiotemporal gait parameters in individuals with T2DM and PAD. To the best of our knowledge, the effects of LFPEMFT on VQ and spatiotemporal gait parameters in patients with T2DM and PAD have not yet been investigated.
- Being tested
- Low-frequency pulsed electromagnetic therapy plus interval exercise training program, Placebo low-frequency pulsed electromagnetic therapy plus interval exercise training program
- Keywords
- Magnetic Field, Peripheral Vascular Diseases, Diabetes
- Medical subject headings
- Peripheral Arterial Disease, Diabetes Mellitus, Type 2, Mobility Limitation, Peripheral Vascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-frequency pulsed electromagnetic therapy plus interval exercise training programBehavioural
Application of Low-frequency pulsed electromagnetic therapy plus interval exercise training program.
Placebo low-frequency pulsed electromagnetic therapy plus interval exercise training programBehavioural
Application of the placebo low-frequency pulsed electromagnetic therapy plus interval exercise training program
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A (received low-frequency pulsed electromagnetic therapy plus interval exercise training program) Receives: Behavioral: Low-frequency pulsed electromagnetic therapy plus interval exercise training program |
| Group B | Placebo comparator | Group B (received placcebo low-frequency pulsed electromagnetic therapy plus the same interval exercise training program) Receives: Behavioral: Placebo low-frequency pulsed electromagnetic therapy plus interval exercise training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the vascular-related quality of life.
Vascular-related quality of life (VQ) was assessed in each participant using the Vascular Quality of Life Questionnaire-6 (VascuQoL-6, English version), a six item, valid and reliable, disease-specific, patient-reported outcome measure designed to assess the quality of life (QOL), monitor disease progression, and quantify treatment outcomes in individuals with PAD.
Measured: From enrollment to the end of treatment at 12 weeks
Change in the spatiotemporal gait parameter, step length.
The step-length spatiotemporal gait parameter (in cm) was assessed in all participants using the GAITRite Walkway System (GAITRite, CIR Systems Inc., USA).
Measured: From enrollment to the end of treatment at 12 weeks
Change in the spatiotemporal gait parameter, step time.
The step-time spatiotemporal gait parameter (in sec) was assessed for all participants using the GAITRite Walkway System (CIR Systems Inc., USA).
Measured: From enrollment to the end of treatment at 12 weeks
Change in the spatiotemporal gait parameter, double Support Time.
The double Support Time spatiotemporal gait parameter (in sec) was assessed for all participants using the GAITRite Walkway System (CIR Systems Inc., USA).
Measured: From enrollment to the end of treatment at 12 weeks
Change in the spatiotemporal gait parameter, cadence.
The cadence spatiotemporal gait parameter (steps/min) was assessed for all participants using the GAITRite Walkway System (CIR Systems Inc., USA).
Measured: From enrollment to the end of treatment at 12 weeks
Change in the spatiotemporal gait parameter, velocity.
The velocity spatiotemporal gait parameter (cm/sec) was assessed for all participants using the GAITRite Walkway System (CIR Systems Inc., USA).
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (1)
Ankle-brachial index
The ABI was assessed in all participants by the same trained professional in accordance with the American Diabetes Association guidelines, using a portable vascular Doppler device (VistaAVS, Summit Systems, USA) equipped with a hand-held 8-MHz prob (transducer).
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Jul 2025
- Primary completion9 Apr 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease (PAD)Studies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ashraf Abdelaal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ashraf Abdelaal, Umm Al-Qura University
- Investigators
- ASHRAF AM ABDELAAL, Ph.D., Principal investigator, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864805
- Sponsor's protocol ID
- UQU-WF_DFRJ020222
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For privacy reasons, data can not be exposed until results' publication. Data summary will be confidentially provided upon request under limited situations and after institution and Ethical Committee permissions.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Electromagnetic Field Therapy on Improving Quality of Life and Gait Performance in Patients With Type 2 Diabetes Mellitus and Peripheral Arterial Disease. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07864805
- Acronym / sponsor ID
- UQU-WF_DFRJ020222
- Keywords
- Magnetic Field, Peripheral Vascular Diseases, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ashraf AbdelaalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 8 Oct 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.
The goal of this clinical trial was to investigate the efficacy of Low frequency pulsed electromagnetic therapy (LFPEMT) in improving vascular-related quality of life (VQ) and spatiotemporal gait parameters in individuals with Type 2 Diabetes mellitus (T2DM) and Peripheral arterial disease (PAD).
The main questions it aimed to answer are:
- Is the LFPEMT effective in improving VQ in patients with T2DM and PAD?
- Is the LFPEMT effective in improving spatiotemporal gait parameters in patients with T2DM and PAD? Researchers compared group A (received LFPEMT plus interval exercise training program) to group B (received placebo LFPEMT plus the same interval exercise training program) to see if LFPEMT is effective in improving gait parameters and vascular related quality of life in patients with T2DM and PAD.
Participants in group A received LFPEMT plus moderate intensity interval training, while participants in group B received placebo LFPEMT plus the same moderate intensity interval training.
Detailed description
Peripheral arterial disease (PAD) is a common diabetes-related complication characterized by narrowing or occlusion of the peripheral arteries [2], most commonly those supplying the lower limbs. This vascular impairment reduces blood flow and predisposes tissues to ischemia and death. Type 2 Diabetes mellitus (T2DM) is a major risk factor for PAD through multidimensional pathogenic pathways, including T2DM-related inflammation, platelet aggregation, and endothelial and vascular smooth muscle dysfunction.
Peripheral arterial disease negatively impacts patient's life that progressively deteriorates as the PAD progress, presented with intermittent claudication, weak peripheral pulse, delayed or non-healing wounds, skin discoloration and cold extremities.
The association between T2DM and PAD has received increasing attention over the past several years. T2DM increases the risk of PAD by two to four times compared with individuals without T2DM. The prevalence of PAD is approximately 20-50% among older adults with diabetes mellitus (DM), and about 12.5-22% among older adults with T2DM. Approximately 15% of patients with DM develop PAD within 10 years, and this ratio increases to 45% after 20 years.
Health-related quality of life (HRQOL) is increasingly recognized as an important indicator for overall health status. Individuals with long-standing T2DM experience deteriorations across physical, psychological, social, and environmental domains of HRQOL. Furthermore, diabetes-related PAD is associated with significantly reduced quality of life, impaired gait performance, and decreased mobility function in older adults. Effective management of PAD is therefore a key factor in improving HRQOL among individuals with DM.
Effective PAD management programs have become an important public health priority, highlighting the need to implement safe, effective, and evidence-based treatment strategies to optimize clinical outcomes and prevent complications in individuals with DM and PAD. Exercise training is an important component of PAD rehabilitation programs because of its established efficacy in increasing walking distance and improving quality of life, reducing cardiovascular disease risk, and enhancing functional performance in individuals with PAD.
Low frequency pulsed electromagnetic therapy (LFPEMT) is a safe, noninvasive therapeutic modality that is commonly used in the management of individuals with T2DM. It has also become an important preventive and therapeutic component of comprehensive management program for individuals with T2DM and PAD. LFPEMT has been reported to improve arterial blood flow in individuals with T2DM and PAD. Incorporating the LFPEMT into T2DM management programs may favorably modulate cardiovascular disease risk, reduce peripheral arterial disease severity, and improve functional outcomes in individuals with T2DM. LFPEMT acts noninvasively to produce neurostimulatory, vasoactive, and analgesic effects, thereby favorably modulating various metabolic, cardiovascular, musculoskeletal, and functional variables in individuals with T2DM.
Despite its favorable effects and wide range of applications, important knowledge gaps remain regarding the efficacy of LFPEMFT in improving vascular-related quality of life (VQ) and spatiotemporal gait parameters in individuals with T2DM and PAD. To the best of our knowledge, the effects of LFPEMFT on VQ and spatiotemporal gait parameters in patients with T2DM and PAD have not yet been investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Behavioral: Low-frequency pulsed electromagnetic therapy plus interval exercise training programGroup A (received low-frequency pulsed electromagnetic therapy plus interval exercise training program) |
| Group B | Placebo comparator | Behavioral: Placebo low-frequency pulsed electromagnetic therapy plus interval exercise training programGroup B (received placcebo low-frequency pulsed electromagnetic therapy plus the same interval exercise training program) |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals aged 60-70 years
- Medically controlled T2DM for more than 5 years, treated with oral antidiabetic medications only.
- Glycated haemoglobin (HbA1c) levels >6.5% and ≤11%.
- Established diagnosis of PAD Stage I and IIa or Rutherford stage 0 and 1.
- Mild peripheral arterial obstruction (0.7< ABI<0.9).
Key exclusion criteria (7 listed)
- 60<age<70 years.
- Insulin therapy.
- Recent infectious or serious cardiopulmonary or neuromusculoskeletal conditions that could compromise participant safety or affect the accuracy of study outcomes.
- Implanted electronic devices.
- Uncontrolled blood pressure.
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 |
|---|---|---|
| Low-frequency pulsed electromagnetic therapy plus interval exercise training programApplication of Low-frequency pulsed electromagnetic therapy plus interval exercise training program. | Behavioural | Group A |
| Placebo low-frequency pulsed electromagnetic therapy plus interval exercise training programApplication of the placebo low-frequency pulsed electromagnetic therapy plus interval exercise training program | Behavioural | Group B |
Primary outcome
Change in the vascular-related quality of life.
Time frame: From enrollment to the end of treatment at 12 weeks
Vascular-related quality of life (VQ) was assessed in each participant using the Vascular Quality of Life Questionnaire-6 (VascuQoL-6, English version), a six item, valid and reliable, disease-specific, patient-reported outcome measure designed to assess the quality of life (QOL), monitor disease progression, and quantify treatment outcomes in individuals with PAD.
Change in the spatiotemporal gait parameter, step length.
Time frame: From enrollment to the end of treatment at 12 weeks
The step-length spatiotemporal gait parameter (in cm) was assessed in all participants using the GAITRite Walkway System (GAITRite, CIR Systems Inc., USA).
Change in the spatiotemporal gait parameter, step time.
Time frame: From enrollment to the end of treatment at 12 weeks
The step-time spatiotemporal gait parameter (in sec) was assessed for all participants using the GAITRite Walkway System (CIR Systems Inc., USA).
Change in the spatiotemporal gait parameter, double Support Time.
Time frame: From enrollment to the end of treatment at 12 weeks
The double Support Time spatiotemporal gait parameter (in sec) was assessed for all participants using the GAITRite Walkway System (CIR Systems Inc., USA).
Change in the spatiotemporal gait parameter, cadence.
Time frame: From enrollment to the end of treatment at 12 weeks
The cadence spatiotemporal gait parameter (steps/min) was assessed for all participants using the GAITRite Walkway System (CIR Systems Inc., USA).
Change in the spatiotemporal gait parameter, velocity.
Time frame: From enrollment to the end of treatment at 12 weeks
The velocity spatiotemporal gait parameter (cm/sec) was assessed for all participants using the GAITRite Walkway System (CIR Systems Inc., USA).
1 secondary outcome
Ankle-brachial index
Time frame: From enrollment to the end of treatment at 12 weeks
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 13 Oct 2026.
- Individual participant dataSharing planned: No. For privacy reasons, data can not be exposed until results' publication. Data summary will be confidentially provided upon request under limited situations and after institution and Ethical Committee permissions.
Related trials for Peripheral Arterial Disease (PAD)
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
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.
ASHRAF AM ABDELAAL, Ph.D. principal investigator
Umm Al-Qura 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 Low-frequency pulsed electromagnetic therapy plus interval exercise training program in people with Peripheral Arterial Disease (PAD) and Diabete Type 2, run by Ashraf Abdelaal at 1 site in Saudi Arabia.
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 7 inclusion and 7 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 13 Oct 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 Saudi Arabia. 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?
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?
Change in the vascular-related quality of life. (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 6 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 13 Oct 2026.