Botulinum Toxin Type A in Diabetic Peripheral Neuropathy

Sponsor
Alexandria University (Other)
Overall Status
Completed
CT.gov ID
NCT05296759
Collaborator
(none)
30
1
3
13.1
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Comparative Study Of Botulinum Toxin Type A Versus Conventional Oral Therapy As A Second Line Treatment Of Diabetic Neuropathy
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
Nov 1, 2021
Actual Study Completion Date :
Mar 8, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: botulinum toxin A injection

botulinum toxin A injection

Drug: botulinum toxin A
botulinum toxin A injection

Active Comparator: gabapentin

gabapentin

Drug: Gabapentin
Gabapentin oral intake

Active Comparator: duloxetine

duloxetine

Drug: Duloxetine
Duloxetine oral drug intake

Outcome Measures

Primary Outcome Measures

  1. visual analogue score [1 week ,4 weeks,12 weeks]

    change visual analogue score zero no pain ,10 unbearable pain

  2. Pittsburgh sleep quality index [1 week ,4 weeks,12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 faculty of medicine Alexandria university Alexandria Egypt

Sponsors and Collaborators

  • Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eman Hamdy, Principal investigator, Alexandria University
ClinicalTrials.gov Identifier:
NCT05296759
Other Study ID Numbers:
  • 2217
First Posted:
Mar 25, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022