An interventional study of FREMS in Chronic Ulcers, sponsored by Beni-Suef University. Not yet recruiting at 1 site in Egypt. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment
The goal of the study is to
Wound ulcers including diabetic foot ulcers impose a substantial and escalating economic burden on healthcare systems worldwide. In the United States alone, chronic wounds affect over 10 million people and account for annual healthcare costs ranging from $28.1 to $96.8 billion. Major challenges persist, including antibiotic resistance, high recurrence rates, delayed healing in patients with comorbidities, and limited evidence for many advanced therapies. Additionally, cost, access to specialized care, and the need for individualized, multidisciplinary management remain significant barriers to optimal outcomes. Using two effective modalities in cases that are resistant to all known treatments, whether they are conservative or adjuvant, is a promising technique to end the entrapment of a wound in a certain stage and avoid complications like further amputation. enrolled patients will be randomly assigned to one of either groups Group A: Intervention group that will receive 3 sessions /week of FERM with phenytoin application with spraying phenytoin topical 40 mg spray after each session according to ulcer size to cover the ulcer.
Group B: Control group that will receive standard of care and will be assessed at baseline and every month till they completed 3 months of treatment.
Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
FREMS therapy 3 sessions/week for 40 minutes with phenytoin spray 40mg.
Device: FREMS
control group: SOC(debridement and basic wound care)
frequency rhythmic electrical stimulation which is an electrical device specialized in diabetes complications like ulcers and neuropathies, with proven efficacy in neuropathies, and promising results in ulcers.
healing rate
wound size
Time frame: measuring once a month for 3 months.
Plan to share: No
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Beni-Suef University