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Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities

NCT05623111 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-10

No results posted yet for this study

Summary

The goal of this clinical trial is to test perineural injections (injections around a nerve) of incobotulinumtoxin-A in participants with diabetic nerve pain of the feet and lower legs.

The main questions it aims to answer are:

* Is the treatment safe and effective?
* Does the treatment affect participants quality of life, depression, physical activity, daily life, and sensation?

Participants will be treated every 12 weeks, for a total of 24 weeks, with either incobotulinumtoxin-A or a placebo.

Conditions

  • Diabetic Neuropathy, Painful

Interventions

DRUG

Incobotulinumtoxin-A 100 UNIT Injection

Perineural injection

DRUG

Saline

Placebo containing trace amounts of human albumin and sucrose, diluted with 5ml of sterile saline.

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    collaborator INDUSTRY

  • Toyota Foundation Denmark

    collaborator UNKNOWN

  • Steno Diabetes Center Zealand Region

    collaborator UNKNOWN

  • Shipwright Per Henriksen, R., and wife Foundation

    collaborator UNKNOWN

  • The GCP unit at Copenhagen University Hospital

    collaborator UNKNOWN

  • Capital Region Pharmacy, Denmark

    collaborator UNKNOWN

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Bo Biering-Sørensen, MD · Neurological Pain Clinic, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2027-05-01
Completion
2027-12-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05623111 on ClinicalTrials.gov