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Evaluation the effect of Botulinium toxin injection on improving symptoms in patients with diabetic neuropathy

Evaluation the effect of Botulinum toxin type A Masport 500 injection on improving pain and quality of life in patients with diabetic neuropathy.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240116060710N1
Enrollment
30
Registered
2024-02-02
Start date
2024-02-20
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic neuropathy.

Interventions

Intervention 1: After covering the perianal bilateral surface of the foot and the front of the ankle with 2% lidocaine ointment, a total of 240 units of botulinum toxin A must be administered (120 uni

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Definite diabetic neuropathy in the plantar area of ??both feet confirmed by NCV. diabetes at least for three years Consistency of the patient's medication for diabetic neuropathy for at least one month before entering the study Filling out a personal consent form to enter the study

Exclusion criteria

Exclusion criteria: Having an underlying disease involving the peripheral nerves that causes symptoms similar to diabetic neuropathy in the plantar area. Change in the patient's medication for diabetic neuropathy during at least one month before entering the study History of myasthenia gravis Allergy to botulinum toxin kidney dysfunction Having a history of alcohol consumption Opioid addiction Presence of pain with a typical dermatomal pattern caused by radiculopathy Lack of patient consent to participate in the study

Design outcomes

Primary

MeasureTime frame
Pain and quality of life and sleep quality of patients. Timepoint: at the begining of the study and in 1-4-8-12 week after intervention. Method of measurement: Evaluation of changes in scores of VAS, PSQI, SF-36 questionnaires.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactYasaman malekzade

Shahid Beheshti University of Medical Sciences

yasimalekztaheri@gmail.com+98 21 5506 2628

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026