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Frequency Rhythmic Electrical Modulated Stimulation Therapy in Chronic Ulcers.

Chronic Ulcer Healing With Frequency Rhythmic Electrical Modulated Stimulation (FREMS)Therapy and Phenytoin Application in Diabetic Patients.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07645495
Acronym
FREMS
Enrollment
26
Registered
2026-06-12
Start date
2026-07-01
Completion date
2026-09-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Ulcers

Brief summary

The goal of the study is to 1. To measure wound size of chronic ulcers after using FREMS therapy and phenytoin application in the interventional group monthly till the end of the third month compared to baseline. 2. To measure wound size of chronic ulcers after using standard of care in control group monthly till the end of the third month compared to baseline. 3. To compare the results of the 2 groups and determine the significance of the treatment.

Detailed description

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.

Interventions

DEVICEFREMS

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.

Sponsors

Beni-Suef University
Lead SponsorOTHER
General Organization for Teaching Hospitals and Institutes
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* chronic ulcers more than 3 months.

Exclusion criteria

* incapable of being in the clinic of diabetic ulcer during treatment period 3 days/ week for 3 months. * severe ischemia that is indicated for a surgery. * infection or osteomyelitis.

Design outcomes

Primary

MeasureTime frameDescription
healing ratemeasuring once a month for 3 months.wound size

Countries

Egypt

Contacts

CONTACTIbtihal Nassar, Msc.
ibtihalnassar@gothi.gov.eg+201151678506

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026