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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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 wo

Первичные конечные точки

• Rate of wound healing [Срок оценки: 3 months]

Вторичные конечные точки (4)

• Tissue histology [Срок оценки: 3 months]
• Tissue immunohistology [Срок оценки: 3 months]
• Oxidative stress marker [Срок оценки: 3 months]
• Inflammatory marker [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Малайзия · 1 центр

• Tuanku Mizan Armed Forces Hospital — Kuala Lumpur

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 34771347
• Haesler, E. (2024). Electrical stimulation therapy for wound healing: a WHAM evidence summary. Wound Practice and Research, 32(3), 163-168.

Идентификаторы

NCT: NCT07465640 · 31/2025 · PKAT/JKEP/76-44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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