MedPath

Evaluation the effect of Botulinium toxin injection on improving symptoms in patients with diabetic neuropathy

Phase 3
Recruiting
Conditions
Diabetic neuropathy.
Registration Number
IRCT20240116060710N1
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

Definite diabetic neuropathy in the plantar area of ??both feet confirmed by NCV.
diabetes at least for three years
Consistency of the patient's medication for diabetic neuropathy for at least one month before entering the study
Filling out a personal consent form to enter the study

Exclusion Criteria

Having an underlying disease involving the peripheral nerves that causes symptoms similar to diabetic neuropathy in the plantar area.
Change in the patient's medication for diabetic neuropathy during at least one month before entering the study
History of myasthenia gravis
Allergy to botulinum toxin
kidney dysfunction
Having a history of alcohol consumption
Opioid addiction
Presence of pain with a typical dermatomal pattern caused by radiculopathy
Lack of patient consent to participate in the study

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain and quality of life and sleep quality of patients. Timepoint: at the begining of the study and in 1-4-8-12 week after intervention. Method of measurement: Evaluation of changes in scores of VAS, PSQI, SF-36 questionnaires.
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath