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Diabetic Foot UlcerNCT07465640

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

A study testing Pulsating electromagnetic field in people with Diabetic Foot Ulcer and Diabetes Mellitus (DM), run by National Defence University of Malaysia at 1 site in Malaysia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot Ulcer, Diabetes Mellitus (DM)
What is being tested?
Pulsating electromagnetic field
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteMalaysia
Study dates
1 Jun 2026to 1 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Khairul Anwar Zarkasi, MBBS, MMedSc., PhD contact

+60178870689

khairul.anwar@upnm.edu.my

Muhammad Jasfizal Jasni, MD, MS contact

+60132587459

jasfizal@upnm.edu.my

Malaysia1 site, 1 recruiting

  • Tuanku Mizan Armed Forces Hospital

    Kuala Lumpur, 57000

    Muhammad Azwan Ibrahim Dr, +601132970402, azwan.ibrahim6189@gmail.com

    Recruiting

Other trials in Malaysia

About this study

Official title: 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.

Being tested
Pulsating electromagnetic field
Keywords
pulsating electromagnetic field, wound healing, oxidative stress, inflammation, diabetic foot ulcer, diabetes mellitus
Medical subject headings
Diabetic Foot, Diabetes Mellitus, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulsating electromagnetic fieldDevice

    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).

Study groups in NCT07465640
Study groupRoleWhat they receive
ControlNo interventionWound dressing only without PEMF
Treatment 1ExperimentalPEMF 1 hour \& wound dressing
Receives: Device: Pulsating electromagnetic field
Treatment 2ExperimentalPEMF 2 hours \& wound dressing
Receives: Device: Pulsating electromagnetic field
Treatment 3ExperimentalPEMF 3 hours \& wound dressing
Receives: Device: Pulsating electromagnetic field

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of wound healing

    Changes in wound size over the study duration

    Measured: 3 months

Secondary outcomes (4)

  1. Tissue histology

    Appearance of wound tissue under haematoxylin and eosin staining.

    Measured: 3 months

  2. Tissue immunohistology

    Expression of vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF) in the wound tissue.

    Measured: 3 months

  3. Oxidative stress marker

    Levels of superoxide dismutase or other oxidative stress biomarkers in the serum

    Measured: 3 months

  4. Inflammatory marker

    Levels of C-reactive protein (CRP) or other inflammatory biomarkers in the serum

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study start1 Jun 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07465640
Sponsor's protocol ID
31/2025
Other IDs
PKAT/JKEP/76-44
Status last verified
Jul 2026
First submitted
6 Mar 2026
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ministry of Health Malaysia (2018). Clinical Practice Guidelines: Management of Diabetic Foot, 2nd Edition. Putrajaya, Malaysia.

  • Sidhu AS, Harbuzova V. Emerging technologies for the management of diabetic foot ulceration: a review. Front Clin Diabetes Healthc. 2024 Nov 12;5:1440209. doi: 10.3389/fcdhc.2024.1440209. eCollection 2024.

    PubMed 39600625

  • Keyan Z, Liqian Z, Xinzhong X, Juehua J, Chungui X. Pulsed Electromagnetic Fields Improved Peripheral Nerve Regeneration After Delayed Repair of One Month. Bioelectromagnetics. 2023 Oct-Dec;44(7-8):133-143. doi: 10.1002/bem.22443. Epub 2023 Jun 5.

    PubMed 37277911

  • Avendano-Coy J, Lopez-Munoz P, Serrano-Munoz D, Comino-Suarez N, Avendano-Lopez C, Martin-Espinosa N. Electrical microcurrent stimulation therapy for wound healing: A meta-analysis of randomized clinical trials. J Tissue Viability. 2022 May;31(2):268-277. doi: 10.1016/j.jtv.2021.12.002. Epub 2021 Dec 4.

    PubMed 34903470

  • Tentolouris, A., Eleftheriadou, I., Samakidou, G., & Tentolouris, N. (2025). Developments in the management of diabetic foot ulcers (Review). World Academy of Sciences Journal, 7, 46.

  • Rabbani M, Rahman E, Powner MB, Triantis IF. Making Sense of Electrical Stimulation: A Meta-analysis for Wound Healing. Ann Biomed Eng. 2024 Feb;52(2):153-177. doi: 10.1007/s10439-023-03371-2. Epub 2023 Sep 24.

    PubMed 37743460

  • Cheah YJ, Buyong MR, Mohd Yunus MH. Wound Healing with Electrical Stimulation Technologies: A Review. Polymers (Basel). 2021 Nov 1;13(21):3790. doi: 10.3390/polym13213790.

    PubMed 34771347

  • Haesler, E. (2024). Electrical stimulation therapy for wound healing: a WHAM evidence summary. Wound Practice and Research, 32(3), 163-168.

  • Abd El Rasheed, N. A. (2017). Pulsed electromagnetic fields versus laser therapy on enhancing recovery of diabetic foot ulcer: A single blind randomized controlled trial. Biomedical Research, 28(19), 8509-8514.

Questions about this trial

What is this clinical trial studying?

A study testing Pulsating electromagnetic field in people with Diabetic Foot Ulcer and Diabetes Mellitus (DM), run by National Defence University of Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Khairul Anwar Zarkasi, MBBS, MMedSc., PhD (+60178870689, khairul.anwar@upnm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of wound healing (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07465640, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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