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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorSouth Valley University

About this trial

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.

Eligibility criteria

Qualifiers

• 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).

Disqualifiers

• Severe peripheral arterial disease (ABPI <0.5).

Active infection requiring hospitalization.

History of amputation.

Cardiac pacemaker or contraindication to EMF therapy.

Trial design

Treatments tested in this trial

  • 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

Treatment groups

79 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators