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

Study acronym: PINBOT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Nov 1, 2025 to May 1, 2027
    • Study completion date: Feb 1, 2026 to Dec 1, 2027
    • Collaborators: 4 to 6
    v5
  2. Primary completion date: Oct 1, 2025 to Nov 1, 2025
    • Start date changed from estimate of Jan 1, 2024 to Aug 1, 2023
    v4
  3. Start date: Jul 1, 2023 to Jan 1, 2024v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Primary completion date: Oct 1, 2024 to Oct 1, 2025
    • Start date: Mar 1, 2023 to Jul 1, 2023
    • Study completion date: Nov 1, 2026 to Feb 1, 2026
    • Interventions: Saline (Drug), Xeomin 100 UNT Injection (Drug) to Incobotulinumtoxin-A 100 UNIT Injection (Drug), Saline (Drug)
    • Eligibility criteria expanded, about 16 words
    • Site details revised
    • Collaborators expanded, about 18 words
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05623111
Lead Sponsor Copenhagen University Hospital, Rigshospitalet
Collaborators: Merz Pharmaceuticals GmbH, Toyota Foundation Denmark, Steno Diabetes Center Zealand Region, Shipwright Per Henriksen, R., and wife Foundation, University of Copenhagen, Region Capital Denmark
Conditions
(from sponsor)		 Diabetic Neuropathy, Painful
Related terms Diabetic Neuropathies
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov