A Phase 4 interventional study of botulinum toxin A and Gabapentin in Diabetic Neuropathies, sponsored by Alexandria University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Alexandria University · Phase 4, Interventional, and Treatment
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.
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.
617 studies on the registry are indexed under Diabetic Neuropathies; 91 are open to participants now.
This study's enrollment of 30 is below the median of 73 across 510 interventional studies indexed under Diabetic Neuropathies.
Browse Diabetic Neuropathies studies →Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
botulinum toxin A injection
Drug: botulinum toxin A
gabapentin
Drug: Gabapentin
duloxetine
Drug: Duloxetine
botulinum toxin A injection
Gabapentin oral intake
Duloxetine oral drug intake
visual analogue score
change visual analogue score zero no pain ,10 unbearable pain
Time frame: 1 week ,4 weeks,12 weeks
Pittsburgh sleep quality index
change Pittsburgh sleep quality index 0-21 ,above 5 indicates sleep disturbance
Time frame: 1 week ,4 weeks,12 weeks
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Alexandria University