NCT07645495

Brief Summary

The goal of the study is to

  1. 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. 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. 3.To compare the results of the 2 groups and determine the significance of the treatment.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 9, 2026

Last Update Submit

June 9, 2026

Conditions

Chronic Ulcers

Outcome Measures

Primary Outcomes (1)

  • healing rate

    wound size

    measuring once a month for 3 months.

Study Arms (2)

chronic ulcers patients

EXPERIMENTAL

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

Device: FREMS

ulcers patients

NO INTERVENTION

control group: SOC(debridement and basic wound care)

Interventions

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.

chronic ulcers patients

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic ulcers more than 3 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National diabetes institute

Giza, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 24142074BACKGROUND

Central Study Contacts

Ibtihal Nassar, Msc.

CONTACT

+201151678506ibtihalnassar@gothi.gov.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist.

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 12, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)