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

RecruitingNAAges 18 Years - anyAllNational Defence University of Malaysia
NCT07465640 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 p

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📋 Eligibility rules (as published)
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.
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What it tests

  • Pulsating electromagnetic field
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Where

1 site
Tuanku Mizan Armed Forces Hospital
Kuala Lumpur, Malaysia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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