The effect of intradermal Dysport injections on painful diabetic polyneuropathy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130518013364N8

Enrollment

141

Registered

2019-11-29

Start date

2019-05-05

Completion date

Unknown

Last updated

2019-12-17

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

Conditions

Condition 1: Diabetic polyneuropathy. Condition 2: Diabetic polyneuropathy. Type 1 diabetes mellitus with diabetic polyneuropathy Type 2 diabetes mellitus with diabetic polyneuropathy

Interventions

Intervention 1: First intervention group: group D1, 150 units BTX- A solved in 2 ml saline normal 0.9%, injected in 20 points of right foot of patients intradermally and in left foot in 20 points sali

Eligibility

Sex/Gender

All

Age

40 Years to 70 Years

Inclusion criteria

Inclusion criteria: diabetic type I or II bilateral symmetric distal polyneuropathy based on the Douleur Neuropathique 4 (DN4) questionnaire and Nerve conduction velocity (NCV) aged between 40 and 70 years old

Exclusion criteria

Exclusion criteria: local infection in lower limbs lumbar radiculopathy neurologic or mental deficit allergy to the botulinum toxin or used NSAIDs or other medications to alleviate the neuropathic pain history of alcohol or opium consume renal disease muscular weakness or atrophy of lower limb history of myasthenia gravis use of aminoglycosides breastfeeding mothers

Design outcomes

Primary

Measure	Time frame
Pain. Timepoint: 4 weeks. Method of measurement: VAS.;Neuropathy Pain Scale (NPS). Timepoint: 4 weeks. Method of measurement: Scores are based on patients responses to questions (NPS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrdad Taheri

Shahid Beheshti University of Medical Sciences

m.taheri@sbmu.ac.ir+98 21 7343 0000

Outcome results

None listed

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