Botulinum Toxin Type A in Diabetic Peripheral Neuropathy

Phase 4

Completed

• Conditions: Diabetic Neuropathies
• Interventions: Drug: Gabapentin; Drug: Duloxetine; Drug: botulinum toxin A

• Registration Number: NCT05296759
• Lead Sponsor: Alexandria University

Brief Summary

Background: Diabetes mellitus is commonly complicated by diabetic peripheral neuropathy. Due to common side effects and poor tolerance to medication, poor adherence to medication is common in diabetic peripheral neuropathy. Botulinum toxin A intradermal injection has proved efficacy in cases of diabetic peripheral neuropathy however there is a need to compare its effect with other lines of treatment. The aim of the study was to compare botulinum toxin type a verses conventional oral treatment as a second line treatment of painful diabetic peripheral neuropathy. This study was conducted as a comparative study on 30 patients with type 2 diabetes mellitus proved by nerve conduction study on carbamazepine. Patients were divided randomly into 3 groups. First group was add on duloxetine, second was add on gabapentin and the third group was injected intradermal with botulinum toxin A.

Detailed Description

This study is a comparative study on 30 patients with type 2 diabetes mellitus proved by nerve conduction study on carbamazepine. Patients were divided randomly into 3 groups.

First group was add on duloxetine, second was add on gabapentin and the third group was injected intradermal with Botulinum toxin A. Base line Assessment before treatment and follow up assessment as performed The treatment options were explained to the patients and the choice of Botulinum toxin A Intradermal injection was the patient own decision based on inability to be tolerate or adhere to oral treatment.

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2021-11-01
• Status Verified: 2022-03
• Study Completion: 2022-03-08
• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-25
• Last Update Submitted: 2022-03-26
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• diabetic patients type 2 were included on single line of treatment with carbamazepine

Exclusion Criteria

• any sever medical condition that might interfere with the results.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gabapentin	Gabapentin	gabapentin
duloxetine	Duloxetine	duloxetine
botulinum toxin A injection	botulinum toxin A	botulinum toxin A injection

Primary Outcome Measures

Name	Time	Method
visual analogue score	1 week ,4 weeks,12 weeks	change visual analogue score zero no pain ,10 unbearable pain
Pittsburgh sleep quality index	1 week ,4 weeks,12 weeks	change Pittsburgh sleep quality index 0-21 ,above 5 indicates sleep disturbance

Trial Locations

Locations (1)

faculty of medicine Alexandria university; 🇪🇬 Alexandria, Egypt