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

Sponsor
South Valley University
Study ID
NCT07070544
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • 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 — 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.

Study Details

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.

Key Dates

First listed
Jul 17, 2025
Start date
Aug 1, 2025
Status verified
Jul 2025
Primary completion
Dec 1, 2025
Completion
Jan 1, 2026

Study Design

Enrollment
79 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Placebo Comparator: The control group
    Standard Care: • Wound care, glycemic control, and patient education as per institutional protocol.

Primary Outcome Measure

Blood flow [ Time Frame: Measurement Timeline: • Minimum value (Baseline)(Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12) ]

Central Contacts

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