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NCT Number: NCT07070544

Effect of Electromagnetic Field Therapy and Customized Foot Insole on Peripheral Circulation and Ankle-Brachial Pressure Index in Patients With Diabetic Foot Ulcer

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.

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Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Diabetes Complications Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcer Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

  • 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?

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  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 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).

Exclusion criteria

  • • Severe peripheral arterial disease (ABPI <0.5).
  • Active infection requiring hospitalization.
  • History of amputation.
  • Cardiac pacemaker or contraindication to EMF therapy.

Treatment and study plan

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

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 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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. • 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)

    • Ankle-Brachial Pressure Index (ABPI): Measured using handheld Doppler.

  2. • 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)

    • Ulcer Healing Rate: Monitored through ulcer size reduction (planimetric tracing and digital photography).

  3. • 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)

    • Pain Level: Measured using the Visual Analog Scale (VAS).

Study contacts

Contact information is provided by the study sponsor or research team.

ibrahim ismail Abuzaid, PhD

CONTACT

[email protected]

+962777956592 ext. +201006512150

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Head of Department of Physical Therapy for Cardiovascular/Respiratory Disorders and Geriatrics

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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