The effect of intradermal Dysport injections on painful diabetic polyneuropathy

Phase 2

• Conditions: Condition 1: Diabetic polyneuropathy. Condition 2: Diabetic polyneuropathy.; Type 1 diabetes mellitus with diabetic polyneuropathy; Type 2 diabetes mellitus with diabetic polyneuropathy; E10.42; E11.42

• Registration Number: IRCT20130518013364N8
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 December 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

diabetic type I or II
bilateral symmetric distal polyneuropathy based on the Douleur Neuropathique 4 (DN4) questionnaire and Nerve conduction velocity (NCV)
aged between 40 and 70 years old

Exclusion Criteria

local infection in lower limbs
lumbar radiculopathy
neurologic or mental deficit
allergy to the botulinum toxin or used NSAIDs or other medications to alleviate the neuropathic pain
history of alcohol or opium consume
renal disease
muscular weakness or atrophy of lower limb
history of myasthenia gravis
use of aminoglycosides
breastfeeding mothers

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain. Timepoint: 4 weeks. Method of measurement: VAS.;Neuropathy Pain Scale (NPS). Timepoint: 4 weeks. Method of measurement: Scores are based on patients responses to questions (NPS).