Botulinum Toxin Type A in Diabetic Peripheral Neuropathy

NCT05296759 | Completed Phase 4 DMC

• 1 other identifier: 2217
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Neuropathies

Outcome Measures

Primary Outcomes (2)

• visual analogue score

  change visual analogue score zero no pain ,10 unbearable pain

  1 week ,4 weeks,12 weeks

• Pittsburgh sleep quality index

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

  1 week ,4 weeks,12 weeks

Study Arms (3)

botulinum toxin A injection

ACTIVE COMPARATOR

botulinum toxin A injection

Drug: botulinum toxin A

gabapentin

ACTIVE COMPARATOR

gabapentin

Drug: Gabapentin

duloxetine

ACTIVE COMPARATOR

duloxetine

Drug: Duloxetine

Interventions

botulinum toxin A DRUG

botulinum toxin A injection

botulinum toxin A injection

Gabapentin DRUG

Gabapentin oral intake

gabapentin

Duloxetine DRUG

Duloxetine oral drug intake

duloxetine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetic patients type 2 were included on single line of treatment with carbamazepine

You may not qualify if:

• any sever medical condition that might interfere with the results.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

faculty of medicine Alexandria university

Alexandria, Egypt

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Botulinum Toxins, Type A; Gabapentin; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 25, 2022
• Study Start: February 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: March 8, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

EG (1)