Botulinum Toxin Type A in Diabetic Peripheral Neuropathy

Diabetic Neuropathies Clinical Trial

Official title:

A Comparative Study Of Botulinum Toxin Type A Versus Conventional Oral Therapy As A Second Line Treatment Of Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05296759
• Other study ID #: 2217
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2021
• Est. completion date: March 8, 2022

Study information

• Verified date: March 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 8, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies

Intervention

Drug:
• botulinum toxin A
botulinum toxin A injection
• Gabapentin
Gabapentin oral intake
• Duloxetine
Duloxetine oral drug intake

Locations

Country	Name	City	State
Egypt	faculty of medicine Alexandria university	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue score	change visual analogue score zero no pain ,10 unbearable pain	1 week ,4 weeks,12 weeks
Primary	Pittsburgh sleep quality index	change Pittsburgh sleep quality index 0-21 ,above 5 indicates sleep disturbance	1 week ,4 weeks,12 weeks