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.
• 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).
• Severe peripheral arterial disease (ABPI <0.5).
Active infection requiring hospitalization.
History of amputation.
Cardiac pacemaker or contraindication to EMF therapy.
Parallel
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
DeviceElectromagnetic 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.
Blood flow
Primary Outcome: • Peripheral Circulation: Assessed by Laser Doppler Flowmetry and/or skin perfusion pressure (SPP).
• Ankle-Brachial Pressure Index (ABPI)
• Ankle-Brachial Pressure Index (ABPI): Measured using handheld Doppler.
• Ulcer Healing Rate
• Ulcer Healing Rate: Monitored through ulcer size reduction (planimetric tracing and digital photography).
• Pain Level:
• Pain Level: Measured using the Visual Analog Scale (VAS).
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
