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Completed

NCT Number: NCT05296759

Botulinum Toxin Type A in Diabetic Peripheral Neuropathy

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.

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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

faculty of medicine Alexandria university

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum toxin A

Drug

botulinum toxin A injection

Gabapentin

Drug

Gabapentin oral intake

Duloxetine

Drug

Duloxetine oral drug intake

Primary outcomes

  1. visual analogue score

    Time frame: 1 week ,4 weeks,12 weeks

    change visual analogue score zero no pain ,10 unbearable pain

  2. Pittsburgh sleep quality index

    Time frame: 1 week ,4 weeks,12 weeks

    change Pittsburgh sleep quality index 0-21 ,above 5 indicates sleep disturbance

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 25, 2022
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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