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Not yet recruitingNCT07645495FREMSUpdated Jun 12, 2026

Frequency Rhythmic Electrical Modulated Stimulation Therapy in Chronic Ulcers.

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

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Chronic Ulcers
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • chronic ulcers more than 3 months.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    chronic ulcers patients

    FREMS therapy 3 sessions/week for 40 minutes with phenytoin spray 40mg.

    Device: FREMS

  • No intervention
    ulcers patients

    control group: SOC(debridement and basic wound care)

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.

06

What researchers measure

Primary outcomes

  1. healing rate

    wound size

    Time frame: measuring once a month for 3 months.

07

Study locations

1 site
08

References and documents

Publications

  • Magnoni C, Rossi E, Fiorentini C, Baggio A, Ferrari B, Alberto G. Electrical stimulation as adjuvant treatment for chronic leg ulcers of different aetiology: an RCT. J Wound Care. 2013 Oct;22(10):525-6, 528-33. doi: 10.12968/jowc.2013.22.10.525. PubMed 24142074 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07645495
Lead sponsor
Beni-Suef University
Collaborators
General Organization for Teaching Hospitals and Institutes
Responsible party
Ibtihal Nassar (physiotherapist., Beni-Suef University) — Principal investigator
First posted
Jun 12, 2026
Start date
Jul 2026 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Jun 12, 2026

Study contacts

Ibtihal Nassar, Msc.
Contact
ibtihalnassar@gothi.gov.eg
+201151678506

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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