NCT05296759 is a Phase 4 clinical trial of botulinum toxin A in Diabetic Neuropathies, sponsored by Alexandria University.

Who is sponsoring NCT05296759?

NCT05296759 is sponsored by Alexandria University.

What drugs are being tested in NCT05296759?

Interventions in NCT05296759: botulinum toxin A, Gabapentin, Duloxetine.

What condition does NCT05296759 study?

NCT05296759 studies Diabetic Neuropathies.

Is NCT05296759 still recruiting?

NCT05296759 is currently completed. Last updated 6 April 2022.

Last reviewed 2022-04-06 · How we verify

NCT05296759

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Botulinum Toxin Type A in Diabetic Peripheral Neuropathy

Completed Phase 4 Last updated 6 April 2022

What this trial tests

Phase 4 trial testing botulinum toxin A in Diabetic Neuropathies in 30 participants. Completed in 8 March 2022.

Timeline

1 February 2021

Primary endpoint
1 November 2021

8 March 2022

Quick facts

Lead sponsor	Alexandria University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 February 2021
Primary completion	1 November 2021
Estimated completion	8 March 2022
Sites	1 location across Egypt

Drugs / interventions tested

botulinum toxin A — full drug profile →
Gabapentin (Gabapentin) — full drug profile →
Duloxetine (duloxetine) — full drug profile →

Conditions studied

Diabetic Neuropathies — all drugs for Diabetic Neuropathies →

Sponsor

Alexandria University

Who can join

Eligibility, any sex, with Diabetic Neuropathies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Innovative strategies for diabetic peripheral neuropathy: From clinical management to emerging bioengineering solutions.
He Z, Diao J, Hamel FG, Duan B. · · 2026 · PMID 41737633 · DOI 10.1016/j.bioactmat.2026.02.023

Verify or expand the search:

Other trials of botulinum toxin A

Trials testing the same drug.

NCT06218316 — Repetitive Transcranial Magnetic Stimulation Versus Botulinum Injection on Spasticity on Children With Diplegic Cerebral · NA · completed
NCT03833063 — Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression · Phase 1 · withdrawn
NCT03187626 — Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis · Phase 2, PHASE3 · completed
NCT03816046 — Hyperhydrosis Treatment Using Botulinum Toxin · Phase 4 · completed
NCT05618470 — Wumeiwan Jiawei Fang Use in Patients With Blepharospasm · Phase 2, PHASE3 · unknown

Other recruiting trials for Diabetic Neuropathies

Currently open trials in the same condition.

NCT07425275 — Integrated Oral Care Intervention for Xerostomia in Diabetes Patients · NA · recruiting
NCT06745544 — Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes · NA · recruiting
NCT06483620 — Cross-cultural Adaptation and Validity of the Arabic-translated NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire · recruiting
NCT06674980 — Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DF · NA · recruiting
NCT06798181 — Neuropathic Pain and Type II Diabetic Patients · recruiting

Other Alexandria University trials

Trials by the same sponsor.

NCT07517861 — Integrated Mental Health Nursing Program: Effects on Stigma, Cognitive Flexibility, and Clinical Readiness · NA · recruiting
NCT07476482 — The Impact of a Shared Decision-Making Intervention on Intraoperative Patient Experience During Elective Cesarean Delive · NA · enrolling by invitation
NCT07476209 — Sialendoscopy Versus Photobiomodulation in Prevention of Radiation Induced Xerostomia · NA · recruiting
NCT07503626 — Optimization of Orthodontic Bracket Placement by Using Two Different Protocols of Digitally Aided Bonding · NA · recruiting
NCT07522944 — AI-Guided Relaxation for Hemodialysis Anxiety · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05296759 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alexandria University
Last refreshed: 6 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05296759.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing