botulinum toxin type A and diabetic neuropathy

Phase 2

• Conditions: Diabeticr polyneuropathy.; Type 2 diabetes mellitus with diabetic polyneuropathy; E10.42

• Registration Number: IRCT20190129042540N1
• Lead Sponsor: Rafsanjan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Having type 2 diabetes for at least 3 years
40-70 years old
providing a positive response to four or more questions in DN4 test
evidence of diabetic neuropathy in lower limb electrophysiological examination

Exclusion Criteria

who were allergic to BTX-A
using other drugs to reduce neuropathic pain
a history of myasthenia gravis
subjects with distal muscle weakness
kidney dysfunction
history of alcohol use
post-operative patients
who initiated taking medication after the onset of the study
who used aminoglycosides
peripheral vascular obstructive disease

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of pain. Timepoint: in the beginning of study and 1, 4, 8, and 12 weeks after intervention. Method of measurement: Pain Visual Analogue Scale.;Quality of life. Timepoint: in the beginning of study and 1, 4, 8, and 12 weeks after intervention. Method of measurement: Short Form-36Quality-of-Life Questionnaire.;Severity and quality of pain. Timepoint: in the beginning of study and 1, 4, 8, and 12 weeks after intervention. Method of measurement: Neuropathic Pain Scale.;Sleep quality. Timepoint: in the beginning of study and 1, 4, 8, and 12 weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Index questionnaire.