Botulinum Toxin Type A in Diabetic Peripheral Neuropathy

NCT ID: NCT05296759

Last Updated: 2022-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-03-08

Brief Summary

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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

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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

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Diabetic Neuropathies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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botulinum toxin A injection

botulinum toxin A injection

Group Type ACTIVE_COMPARATOR

botulinum toxin A

Intervention Type DRUG

botulinum toxin A injection

gabapentin

gabapentin

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Gabapentin oral intake

duloxetine

duloxetine

Group Type ACTIVE_COMPARATOR

Duloxetine

Intervention Type DRUG

Duloxetine oral drug intake

Interventions

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botulinum toxin A

botulinum toxin A injection

Intervention Type DRUG

Gabapentin

Gabapentin oral intake

Intervention Type DRUG

Duloxetine

Duloxetine oral drug intake

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Eman Hamdy

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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faculty of medicine Alexandria university

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2217

Identifier Type: -

Identifier Source: org_study_id

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