An interventional study of Low-frequency pulsed electromagnetic therapy plus interval exercise training program and Placebo low-frequency pulsed electromagnetic therapy plus interval exercise training program in Peripheral Arterial Disease (PAD), Diabete Type 2 and Gait Abnormality, sponsored by Ashraf Abdelaal. Completed at 1 site in Saudi Arabia. Open to participants aged 60 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Ashraf Abdelaal · Not applicable, Interventional, and Treatment
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:
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.
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.
1,573 studies on the registry are indexed under Peripheral Arterial Disease; 284 are open to participants now.
This study's enrollment of 60 is below the median of 73 across 1,078 interventional studies indexed under Peripheral Arterial Disease.
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Exclusion Criteria:
Group A (received low-frequency pulsed electromagnetic therapy plus interval exercise training program)
Behavioral: Low-frequency pulsed electromagnetic therapy plus interval exercise training program
Group B (received placcebo low-frequency pulsed electromagnetic therapy plus the same interval exercise training program)
Behavioral: Placebo low-frequency pulsed electromagnetic therapy plus interval exercise training program
Application of Low-frequency pulsed electromagnetic therapy plus interval exercise training program.
Application of the placebo low-frequency pulsed electromagnetic therapy plus interval exercise training program
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: From enrollment to the end of treatment at 12 weeks
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).
Time frame: From enrollment to the end of treatment at 12 weeks
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Jul 2025 to primary completion in Apr 2026, 9 months.
Of 276 non-industry interventional studies with no phase under Peripheral Arterial Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 63. This study's 9 months is below that.
Counting every sponsor, half of 401 studies reached it within 31 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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