Effect of Electromagnetic Field Therapy and Customized Foot Insole on Peripheral Circulation and Ankle-Brachial Pressure Index in Patients With Diabetic Foot Ulcer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Diabetic Foot Ulcer. Basic parameters: 40 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Head of Department of Physical Therapy for Cardiovascular/Respiratory Disorders and Geriatrics
Overview
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
- 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
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.
Primary outcome measures
- 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)]
Secondary outcome measures (3)
- • Ankle-Brachial Pressure Index (ABPI) [Time frame: Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)]
- • Ulcer Healing Rate [Time frame: Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)]
- • Pain Level: [Time frame: Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Burhan A, Arofiati F, Da Silva VA, Sebayang SM. Effect of Ankle Brachial Index (ABI) and Compression Therapy on Diabetic Foot Ulcer Healing. Curr Diabetes Rev. 2024;20(1):e310323215277. doi: 10.2174/1573399819666230331083420. PMID 37005544
Identifiers
NCT: NCT07070544 · South Valley University PTh