drugset / Trial / NCT05296759

Botulinum Toxin Type A in Diabetic Peripheral Neuropathy

NCT05296759

Phase 4 Completed 30 enrolled Alexandria University
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-02-01
Primary completion
2021-11-01
Completion
2022-03-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic Other
Comparator Duloxetine Small molecule Oral
Comparator Gabapentin Small molecule Oral

Indications