NCT05296759

Botulinum Toxin Type A in Diabetic Peripheral Neuropathy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Neuropathies

Interventions

Type	Name	Description
DRUG	botulinum toxin A	botulinum toxin A injection
DRUG	Gabapentin	Gabapentin oral intake
DRUG	Duloxetine	Duloxetine oral drug intake

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-11-01
• Completion: 2022-03-08
• First posted: 2022-03-25
• Last updated: 2022-04-06

Locations

1 site across 1 country: Egypt