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