Pulsating electromagnetic field therapy for diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates the safety and potential efficacy of pulsating electromagnetic field therapy (PEMF) using the CRAD ULCER X-01 device in adults with chronic diabetic foot ulcers. Thirty-two participants with non-healing DFUs are recruited and assigned to a treatment or control group, with all receiving daily wound dressing and standard care; the treatment group uses PEMF for one hour daily. The study aims to see if PEMF can accelerate wound healing, reduce inflammation, and improve outcomes compared with standard care alone. Details on device parameters and full protocol are limited in the provided materials. The trial is conducted at Tuanku Mizan Armed Forces Hospital in Kuala Lumpur, led by the National Defence University of Malaysia.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tuanku Mizan Armed Forces Hospital
  Kuala Lumpur, Malaysia Recruiting

Study contacts

• Study coordinator: Khairul Anwar Zarkasi, MBBS, MMedSc., PhD
• Email: khairul.anwar@upnm.edu.my
• Phone: +60178870689

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.