Diabetes Mellitus, Diabetic Foot Ulcer
Conditions
Keywords
Effect of Electromagnetic Field Therapy, Customized Foot Insole, Peripheral Circulation, Ankle-Brachial Pressure Index
Brief summary
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.
Detailed 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 1. Does the combination of EMF therapy and customized foot insoles improve peripheral circulation in patients with diabetic foot ulcers? 2. Is there a significant improvement in ABPI in the intervention group compared to control? 3. What is the effect of the intervention on ulcer healing rates and pain reduction? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 4. 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.
Interventions
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
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.
Sponsors
South Valley University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood flow | Measurement Timeline: • Minimum value (Baseline)(Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12) | Primary Outcome: • Peripheral Circulation: Assessed by Laser Doppler Flowmetry and/or skin perfusion pressure (SPP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • Ankle-Brachial Pressure Index (ABPI) | Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12) | • Ankle-Brachial Pressure Index (ABPI): Measured using handheld Doppler. |
| • Ulcer Healing Rate | Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12) | • Ulcer Healing Rate: Monitored through ulcer size reduction (planimetric tracing and digital photography). |
| • Pain Level: | Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12) | • Pain Level: Measured using the Visual Analog Scale (VAS). |
Contacts
Primary Contactibrahim ismail Abuzaid, PhD
Outcome results
None listed