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

NCT07465640 | Recruiting

• 2 other identifiers: 31/2025PKAT/JKEP/76-44
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus (DM); Diabetic Foot Ulcer

Keywords

pulsating electromagnetic field; wound healing; oxidative stress; inflammation; diabetic foot ulcer; diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Rate of wound healing

  Changes in wound size over the study duration

  3 months

Secondary Outcomes (4)

• Tissue histology

  3 months

• Tissue immunohistology

  3 months

• Oxidative stress marker

  3 months

• Inflammatory marker

  3 months

Other Outcomes (1)

• Glycated haemoglobin

  3 months

Study Arms (4)

Control

NO INTERVENTION

Wound dressing only without PEMF

Treatment 1

EXPERIMENTAL

PEMF 1 hour \& wound dressing

Device: Pulsating electromagnetic field

Treatment 2

EXPERIMENTAL

PEMF 2 hours \& wound dressing

Device: Pulsating electromagnetic field

Treatment 3

EXPERIMENTAL

PEMF 3 hours \& wound dressing

Device: Pulsating electromagnetic field

Interventions

Pulsating electromagnetic field DEVICE

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).

Treatment 1; Treatment 2; Treatment 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Defence University of Malaysia: lead

Study Sites (1)

Tuanku Mizan Armed Forces Hospital

Kuala Lumpur, 57000, Malaysia

RECRUITING

Related Publications (9)

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

  BACKGROUND

• 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.

  PMID: 39600625 BACKGROUND

• 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.

  PMID: 37277911 BACKGROUND

• 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.

  PMID: 34903470 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 37743460 BACKGROUND

• 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.

  PMID: 34771347 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Inflammation

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Khairul Anwar Zarkasi, MBBS, MMedSc., PhD

CONTACT

+60178870689; khairul.anwar@upnm.edu.my

Muhammad Jasfizal Jasni, MD, MS

CONTACT

+60132587459; jasfizal@upnm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

MY (1)