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

July 27, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 57000
        • Recruiting
        • Tuanku Mizan Armed Forces Hospital
        • Contact:

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Defence University of Malaysia

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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