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

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus; Diabetic Foot Ulcer

• Registration Number: NCT07070544
• Lead Sponsor: South Valley University

Brief 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. 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

2. 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.

3. Research Questions

1. Does the combination of EMF therapy and customized foot insoles improve peripheral circulation in patients with diabetic foot ulcers?

2. Is there a significant improvement in ABPI in the intervention group compared to control?

3. What is the effect of the intervention on ulcer healing rates and pain reduction?

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4. 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 Timeline

• Study First Submitted: 2025-06-08
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-16
• Last Update Submitted: 2025-07-16
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17
• Study Start: 2025-08-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood flow	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 Outcome Measures

Name	Time	Method
• Ankle-Brachial Pressure Index (ABPI)	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.
• Ulcer Healing Rate	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).
• Pain Level:	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).