NCT07645482

Brief Summary

It's estimated that 50% of diabetic patients will have peripheral neuropathy as a complication within 3 years of the diabetes incidence \[14\], the goal of the study is to investigate this problem through the following objectives:

  1. 1.To measure the effect of using FREMS therapy in diabetic neuropathy in interventional group on the blood perfusion, neuropathy severity and quality of life after 10 sessions compared to baseline.
  2. 2.To measure the effect of using standard of care in diabetic neuropathy in control group on the blood perfusion, neuropathy severity and quality of life after 10 sessions compared to baseline.
  3. 3.To compare the results between both interventional and control group.

Trial Health

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Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo 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
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 9, 2026

Last Update Submit

June 9, 2026

Conditions

Peripheral Neuropathy With Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Neuropathy severity

    neuropathy symptoms like (tingling, numbness, pain, loss of sensation) will be measured through neuropathy impairment score(NIS)

    From enrollment to the end of treatment at 10:14 days

  • blood perfusion.

    effect of FREMS on blood perfusion by duplex.

    From enrollment to the end of treatment at 10:14days.

Secondary Outcomes (1)

  • neuropathy effect in quality of life

    From enrollment to the end of treatment at 10:14days.

Study Arms (2)

(FREMS group)

EXPERIMENTAL
Device: frequency rhythmic electrical modulated stimulation.

conservative treatment.

ACTIVE COMPARATOR
Drug: Duloxetine - low dose

Interventions

Duloxetine - low doseDRUG

peripheral neuropathy conventional treatment, 30:60mg orally once/day within 10:14 days.

conservative treatment.
frequency rhythmic electrical modulated stimulation.DEVICE

FREMS is characterized by sequences of biphasic electrical stimuli, with 10 consecutive sessions applied on lower limb within 10:14 days, 40 minutes for each session.

Also known as: FREMS
(FREMS group)

Eligibility Criteria

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

You may qualify if:

  • patients diagnosed with DM
  • patients age group above 40 years old.
  • patient diagnosed with peripheral neuropathy with symptoms lasts more than 3 months.
  • patients lower limb ischemia in duplex affected APSV.

You may not qualify if:

  • patients with implant peacemakers, defibrillator, or neurostimulator.
  • pregnancy.
  • any severe disease prevent compliance to study procedures.
  • patients with disabilities prevent their commitment to sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National diabetes institute

Giza, Egypt

Location

Related Publications (1)

  • Iqbal Z, Azmi S, Yadav R, Ferdousi M, Kumar M, Cuthbertson DJ, Lim J, Malik RA, Alam U. Diabetic Peripheral Neuropathy: Epidemiology, Diagnosis, and Pharmacotherapy. Clin Ther. 2018 Jun;40(6):828-849. doi: 10.1016/j.clinthera.2018.04.001. Epub 2018 Apr 30.

    PMID: 29709457BACKGROUND

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ayman abdallah., phd

    Beni-Suef University

    STUDY DIRECTOR

Central Study Contacts

Ibtihal Nassar, Bsc, Msc.

CONTACT

+201151678506scholaribtihal@gmail.com

Ibtihal Nassar

CONTACT

01151678506scholaribtihal@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
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)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)