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NCT05623111: PINBOT
Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities
Phase 2 trial testing Incobotulinumtoxin-A 100 UNIT Injection in Diabetic Neuropathy, Painful in 80 participants. Currently enrolling.
1 May 2027
Quick facts
| Lead sponsor | Rigshospitalet, Denmark |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 August 2023 |
| Primary completion | 1 May 2027 |
| Estimated completion | 1 December 2027 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Incobotulinumtoxin-A 100 UNIT Injection — full drug profile →
- Saline
Conditions studied
- Diabetic Neuropathy, Painful — all drugs for Diabetic Neuropathy, Painful →
Sponsor
Rigshospitalet, Denmark
Who can join
18 and older, any sex, with Diabetic Neuropathy, Painful. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Perineural injections of incobotulinumtoxin-A for diabetic neuropathic pain of the lower extremities: protocol for a phase II, single-centre, double-blind, randomised, placebo-controlled trial (the PINBOT study).
Klee M, Hørmann Thomsen T, Enggaard TP, Bitsch MS, et al · · 2024 · cited 2× · PMID 38262642 · DOI 10.1136/bmjopen-2023-074372 -
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:
- PubMed search for NCT05623111
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07511439 — Reversible Effects of Oral Contraceptive Removal on Serotonergic Neurotransmission · Phase 4 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05623111 (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 Rigshospitalet, Denmark
- Last refreshed: 10 December 2025
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/NCT05623111.
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