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

South Valley University

Status: Not yet enrolling

Conditions: Diabetes Mellitus; Diabetic Foot Ulcer

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT07070544

South Valley University PTh

Details and patient eligibility

About

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.

Full 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

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

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

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

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  7. 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.

Enrollment: 79 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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79 participants in 2 patient groups, including a placebo group

The study Group

Active Comparator group

Description:

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.

Treatment:

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

The control group

Placebo Comparator group

Description:

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

Treatment:

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