Chronic UlcersFREMSNCT07645495
Frequency Rhythmic Electrical Modulated Stimulation Therapy in Chronic Ulcers.
A study testing FREMS in people with Chronic Ulcers, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Ulcers
- What is being tested?
- FREMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic ulcers more than 3 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
National diabetes institute
Giza
Ibtihal Nassar, Msc., +201151678506, scholaribtihal@gmail.com
seham abdelmoghny, phd, +201006920495, ibtihalnassar@gothi.gov.eg
About this study
Official title: Chronic Ulcer Healing With Frequency Rhythmic Electrical Modulated Stimulation (FREMS)Therapy and Phenytoin Application in Diabetic Patients.
The goal of the study is to
- 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.
- 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.
- 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.
- Conditions
- Chronic Ulcers
- Being tested
- FREMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FREMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| chronic ulcers patients | Experimental | FREMS therapy 3 sessions/week for 40 minutes with phenytoin spray 40mg. Receives: Device: FREMS |
| ulcers patients | No intervention | control group: SOC(debridement and basic wound care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing rate
wound size
Measured: measuring once a month for 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- General Organization for Teaching Hospitals and Institutes
- Responsible party
- Principal investigator, Ibtihal Nassar, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645495
- Sponsor's protocol ID
- IDE00360
- Acronym
- FREMS
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Ulcer Healing With Frequency Rhythmic Electrical Modulated Stimulation (FREMS)Therapy and Phenytoin Application in Diabetic Patients.
- ClinicalTrials.gov ID
- NCT07645495
- Acronym / sponsor ID
- FREMS / IDE00360
- Conditions
- Chronic Ulcers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- General Organization for Teaching Hospitals and Institutes
- Study start
- Jul 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic ulcers patients | Experimental | Device: FREMSFREMS therapy 3 sessions/week for 40 minutes with phenytoin spray 40mg. |
| ulcers patients | No intervention | –control group: SOC(debridement and basic wound care) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic ulcers more than 3 months.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FREMSfrequency 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. | Device | chronic ulcers patients |
Primary outcome
healing rate
Time frame: measuring once a month for 3 months.
wound size
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 24142074Magnoni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FREMS in people with Chronic Ulcers, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibtihal Nassar, Msc. (+201151678506, ibtihalnassar@gothi.gov.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing rate (time frame: measuring once a month for 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07645495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.