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

Sponsor
National Defence University of Malaysia
Study ID
NCT07465640
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

First listed
Mar 12, 2026
Start date
Mar 13, 2026
Status verified
Mar 2026
Primary completion
Sep 1, 2026
Completion
Apr 1, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control
    Wound dressing only without PEMF
  • Experimental: Treatment 1
    PEMF 1 hour \& wound dressing
  • Experimental: Treatment 2
    PEMF 2 hours \& wound dressing
  • Experimental: Treatment 3
    PEMF 3 hours \& wound dressing

Primary Outcome Measure

Rate of wound healing [ Time Frame: 3 months ]

Central Contacts

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