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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.
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
Does the combination of EMF therapy and customized foot insoles improve peripheral circulation in patients with diabetic foot ulcers?
Is there a significant improvement in ABPI in the intervention group compared to control?
What is the effect of the intervention on ulcer healing rates and pain reduction?
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study Group | Active Comparator | Electromagnetic Field Therapy:
Customized Foot Insoles:
Standard Care: • Wound care, glycemic control, and patient education as per institutional protocol. |
|
| The control group | Placebo Comparator | Standard Care: • Wound care, glycemic control, and patient education as per institutional protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
Customized Foot Insoles:
Standard Care: • Wound care, glycemic control, and patient education as per institutional protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood flow | Primary Outcome: • Peripheral Circulation: Assessed by Laser Doppler Flowmetry and/or skin perfusion pressure (SPP). | Measurement Timeline: • Minimum value (Baseline)(Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| • Ankle-Brachial Pressure Index (ABPI) | • Ankle-Brachial Pressure Index (ABPI): Measured using handheld Doppler. | Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12) |
| • Ulcer Healing Rate |
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Inclusion Criteria:
• Diagnosed with Type 2 Diabetes Mellitus.
Exclusion Criteria:
• Severe peripheral arterial disease (ABPI <0.5).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ibrahim ismail Abuzaid, PhD | Contact | +962777956592 | +201006512150 | ibrahim_ismail_2011@svu.edu.eg |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37005544 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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|
• Ulcer Healing Rate: Monitored through ulcer size reduction (planimetric tracing and digital photography). |
| Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12) |
| • Pain Level: | • Pain Level: Measured using the Visual Analog Scale (VAS). | Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12) |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |
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