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NOT YET RECRUITING
NCT07645482
NA

Frequency Rhythmic Electrical Modulated Stimulation Effect in Peripheral Neuropathy Patients Severity of Cases and Qol.

Sponsor: Beni-Suef University

View on ClinicalTrials.gov

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. 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. 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. To compare the results between both interventional and control group.

Official title: Effects Of Frequency Rhythmic Electrical Modulated Stimulation (FREMS) On Blood Perfusion, Neuropathy Severity And Quality Of Life In Diabetic Patients With Peripheral Neuropathy And Lower Limb Ischemia: A Randomized Controlled Trial.

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-07

Completion Date

2026-08

Last Updated

2026-07-21

Healthy Volunteers

No

Interventions

DEVICE

frequency rhythmic electrical modulated stimulation.

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.

DRUG

Duloxetine - low dose

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

Locations (1)

National diabetes institute

Giza, Egypt