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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-01-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diabetes Mellitus Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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The study Group

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.

Group Type 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

Intervention Type 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.

The control group

Standard Care:

• Wound care, glycemic control, and patient education as per institutional protocol.

Group Type PLACEBO_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

Intervention Type 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.

Interventions

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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

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes