Botulinum Toxin Type A in Diabetic Peripheral Neuropathy

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Diabetic Neuropathies

Treatments: Drug: botulinum toxin A; Drug: Gabapentin; Drug: Duloxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT05296759

2217

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

botulinum toxin A injection

Active Comparator group

Description:

botulinum toxin A injection

Treatment:

Drug: botulinum toxin A

gabapentin

Active Comparator group

Description:

gabapentin

Treatment:

Drug: Gabapentin

duloxetine

Active Comparator group

Description:

duloxetine

Treatment:

Drug: Duloxetine