Botulinum Toxin Type A in Diabetic Peripheral Neuropathy
Primary Purpose
Diabetic Neuropathies
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
botulinum toxin A
Gabapentin
Duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathies
Eligibility Criteria
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.
Sites / Locations
- faculty of medicine Alexandria university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
botulinum toxin A injection
gabapentin
duloxetine
Arm Description
botulinum toxin A injection
gabapentin
duloxetine
Outcomes
Primary Outcome Measures
visual analogue score
change visual analogue score zero no pain ,10 unbearable pain
Pittsburgh sleep quality index
change Pittsburgh sleep quality index 0-21 ,above 5 indicates sleep disturbance
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05296759
Brief Title
Botulinum Toxin Type A in Diabetic Peripheral Neuropathy
Official Title
A Comparative Study Of Botulinum Toxin Type A Versus Conventional Oral Therapy As A Second Line Treatment Of Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
March 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulinum toxin A injection
Arm Type
Active Comparator
Arm Description
botulinum toxin A injection
Arm Title
gabapentin
Arm Type
Active Comparator
Arm Description
gabapentin
Arm Title
duloxetine
Arm Type
Active Comparator
Arm Description
duloxetine
Intervention Type
Drug
Intervention Name(s)
botulinum toxin A
Intervention Description
botulinum toxin A injection
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin oral intake
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
Duloxetine oral drug intake
Primary Outcome Measure Information:
Title
visual analogue score
Description
change visual analogue score zero no pain ,10 unbearable pain
Time Frame
1 week ,4 weeks,12 weeks
Title
Pittsburgh sleep quality index
Description
change Pittsburgh sleep quality index 0-21 ,above 5 indicates sleep disturbance
Time Frame
1 week ,4 weeks,12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
faculty of medicine Alexandria university
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
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Botulinum Toxin Type A in Diabetic Peripheral Neuropathy
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