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

NCT07070544 | Not Yet Recruiting DMC

• 1 other identifier: South Valley University PTh
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus; Diabetic Foot Ulcer

Keywords

Effect of Electromagnetic Field Therapy; Customized Foot Insole; Peripheral Circulation; Ankle-Brachial Pressure Index

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• • 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)

• • Ulcer Healing Rate

  Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)

• • Pain Level:

  Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)

Study Arms (2)

The study Group

ACTIVE COMPARATOR

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.

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

The control group

PLACEBO COMPARATOR

Standard Care: • Wound care, glycemic control, and patient education as per institutional protocol.

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

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.

The control group; The study Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Severe peripheral arterial disease (ABPI \<0.5).
• Active infection requiring hospitalization.
• History of amputation.
• Cardiac pacemaker or contraindication to EMF therapy.

Sponsors & Collaborators

• South Valley University: lead

Related Publications (1)

• 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 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Central Study Contacts

ibrahim ismail Abuzaid, PhD

CONTACT

+962777956592; ibrahim_ismail_2011@svu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ibrahim ismail Abuzaid

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: July 17, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07