Evaluating the Efficacy of Pulsating Electromagnetic Field Therapy by CRAD ULCER X-01 for Diabetic Foot Ulcers

March 11, 2026 updated by: National Defence University of Malaysia

Evaluating the Efficacy of Pulsating Electromagnetic Field (PEMF) Therapy for Diabetic Foot Ulcers Using the CRAD ULCER X-01 Device: A Randomised Parallel-Group Pilot Study

Background: Diabetic foot ulcer (DFU) is a frequent complication of chronic, uncontrolled diabetes mellitus (DM). Treatment with antibiotics, daily dressing, wound debridement, and wound off-loading is often prescribed. However, many DFU patients still progress into severe outcomes, including non-healing of wounds, infections, necrosis, and osteomyelitis. Prior research has shown that the application of pulsating electromagnetic field (PEMF) could accelerate wound healing, including in those afflicted with DFUs. Therefore, this study aimed to evaluate the efficacy of a locally developed CRAD ULCER X-01 device that uses the principles of PEMF in promoting DFU healing. Methods: A total of 32 patients with chronic, non-healing DFUs will be recruited from the Orthopaedic Clinic of Hospital Angkatan Tentera Tuanku Mizan and divided into control (C) (n=8) and treatment (T) (n=24) groups. All patients will receive a standard daily dressing. The PEMF will be supplemented for 1 hour/day, 2 hours/day, and 3 hours/day for T1, T2, and T3 subgroups, respectively (n=8 per group); whereas the C group will be controlled for placebo effect (device in-place but switched off). The therapy duration will be until the wound is closed or for a maximum period of three months. All patients will undergo wound assessment, wound edge tissue histology by haematoxylin and eosin (H&E) staining, and immunohistology (for vascular endothelial growth factor [VEGF] and fibroblast growth factor 2 [FGF-2] expression), as well as serum superoxide dismutase (SOD) and C-reactive protein (CRP) at preand post-treatment, along with glycated haemoglobin (HbA1c) measurement only at post-treatment to control for confounder (i.e., glucose control for the past three months). This study hypothesizes that PEMF therapy by CRAD ULCER X-01 device will accelerate DFU healing and improve tissue integrity, with minimal systemic effects assessed via oxidative stress and inflammatory markers. Conclusion: The results from this study will validate PEMF's effectiveness in promoting DFU healing and establish the potential use of locally developed CRAD ULCER X-01 devices as supplementary therapy to standard DFU care.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Provision of written consent by subjects.
  • Subject of either sex.
  • At least 18 years of age.
  • Known diabetes mellitus.
  • Diagnosed with chronic DFU Grade I-III and Stage A according to the University of Texas Classification as recommended in the Malaysian Clinical Practice Guidelines for the Management of Diabetic Foot (2nd Edition).

Exclusion Criteria:

  • Inability or unwillingness to provide written consent.
  • Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.
  • Other medical conditions which, in the investigator's judgement, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
  • Participation in another clinical trial and/or recipient of investigational therapy within 4 weeks prior to screening visit.
  • Patients who have metal implants in any part of the body.
  • Patients with a pacemaker.
  • History of malignancies.
  • Presence of chronic kidney disease co-morbidity.
  • Presence of severe peripheral artery disease, assessed when the ankle-brachial index (ABI) is <0.40.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Wound dressing only without PEMF
Experimental: Treatment 1
PEMF 1 hour & wound dressing
Device: Pulsating electromagnetic field
The intervention in this study is PEMF therapy using CRAD ULCER X-01, which will be given to chronic DFU patients alongside wound dressing. The device projects high-voltage, high-frequency, and low-current electrical stimulation to the DFU wounds. The device operates in a stationary state at the lower end of the hospital bed of patients who are being treated. This is because it depends solely on the wall socket power source (100/220/240V-AC, 50/60 HZ input Supply). The position of the machine would be adjusted and locked using the adapted roller stand in the proximity of the patient's foot. The elevation of the device would then be adjusted through the adapted mechanical arm, allowing the air channel to face the patient's foot while having a gap of 10-15 cm in between the patient's wound and the air beam (non-contact).
Experimental: Treatment 2
PEMF 2 hours & wound dressing
Device: Pulsating electromagnetic field
The intervention in this study is PEMF therapy using CRAD ULCER X-01, which will be given to chronic DFU patients alongside wound dressing. The device projects high-voltage, high-frequency, and low-current electrical stimulation to the DFU wounds. The device operates in a stationary state at the lower end of the hospital bed of patients who are being treated. This is because it depends solely on the wall socket power source (100/220/240V-AC, 50/60 HZ input Supply). The position of the machine would be adjusted and locked using the adapted roller stand in the proximity of the patient's foot. The elevation of the device would then be adjusted through the adapted mechanical arm, allowing the air channel to face the patient's foot while having a gap of 10-15 cm in between the patient's wound and the air beam (non-contact).
Experimental: Treatment 3
PEMF 3 hours & wound dressing
Device: Pulsating electromagnetic field
The intervention in this study is PEMF therapy using CRAD ULCER X-01, which will be given to chronic DFU patients alongside wound dressing. The device projects high-voltage, high-frequency, and low-current electrical stimulation to the DFU wounds. The device operates in a stationary state at the lower end of the hospital bed of patients who are being treated. This is because it depends solely on the wall socket power source (100/220/240V-AC, 50/60 HZ input Supply). The position of the machine would be adjusted and locked using the adapted roller stand in the proximity of the patient's foot. The elevation of the device would then be adjusted through the adapted mechanical arm, allowing the air channel to face the patient's foot while having a gap of 10-15 cm in between the patient's wound and the air beam (non-contact).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of wound healing
Time Frame: 3 months
Changes in wound size over the study duration
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue histology
Time Frame: 3 months
Appearance of wound tissue under haematoxylin and eosin staining.
3 months
Tissue immunohistology
Time Frame: 3 months
Expression of vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF) in the wound tissue.
3 months
Oxidative stress marker
Time Frame: 3 months
Levels of superoxide dismutase or other oxidative stress biomarkers in the serum
3 months
Inflammatory marker
Time Frame: 3 months
Levels of C-reactive protein (CRP) or other inflammatory biomarkers in the serum
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated haemoglobin
Time Frame: 3 months
Levels of HbA1c in the blood
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Defence University of Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 13, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31/2025
  • PKAT/JKEP/76-44 (Other Identifier: Armed Forces Health Services, Malaysian Armed Forces)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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