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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities: A Double-blind, Randomized, Placebo-controlled Study

Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities (NCT05623111) is a Phase 2 interventional studying Diabetic Neuropathy, Painful, sponsored by Rigshospitalet, Denmark. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Diabetic Neuropathy, Painful and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 80 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Diabetic Neuropathy, Painful subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Are 18 years or older - Are diagnosed with diabetes type I or II - Score 3 or above on the Doleur Neuropathique 4 interview section - Suffer from pain of the lower extremities which - is considered by the participant as their dominant overall dominant pain - is rated at least 4 out of 10 of the NRS pain scale in both legs (on average over the past 7 days) - is present in both feet, roughly symmetrically. - has been present for at least 6 months - Show sensory deficits and/or allodynia or hyperalgesia in the painful area, consistent with the IASP definition of probable chronic neuropathic pain40. - Are in a stable analgesic treatment regime for at least 1 month prior to inclusion and for the duration of the study - Are using an approved, safe contraceptive (for premenopausal women) - Speak, read, and understand Danish Who Should NOT Join This Trial: - • Have a known allergy or hypersensitivity to BonT-A - Have been treated with BonT in the last 6 months. - Are diagnosed with myasthenia, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis - Have a known malignant condition - Have an ongoing infection in the area of injection - Are expecting to change their pain medication during the study period - Have been treated with topical agents such as capsaicin or lidocaine products in the affected areas for at least 3 months prior to inclusion - Are diagnosed with a competing cause of central or peripheral neuropathic pain, or other painful chronic conditions of the lower extremities, such as: - spinal stenosis - claudication - previous trauma or nerve injury - cancer related pain - Have a psychiatric condition that affects their completion of the study, as assessed by the investigator. - Are active abusers of alcohol or illegal substances - Are using or receiving treatment with cannabis products of any kind - Are pregnant or planning pregnancy during the study period - Score more than 12 on the Charlson Comorbidity Index Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Are 18 years or older * Are diagnosed with diabetes type I or II * Score 3 or above on the Doleur Neuropathique 4 interview section * Suffer from pain of the lower extremities which * is considered by the participant as their dominant overall dominant pain * is rated at least 4 out of 10 of the NRS pain scale in both legs (on average over the past 7 days) * is present in both feet, roughly symmetrically. * has been present for at least 6 months * Show sensory deficits and/or allodynia or hyperalgesia in the painful area, consistent with the IASP definition of probable chronic neuropathic pain40. * Are in a stable analgesic treatment regime for at least 1 month prior to inclusion and for the duration of the study * Are using an approved, safe contraceptive (for premenopausal women) * Speak, read, and understand Danish Exclusion Criteria: * • Have a known allergy or hypersensitivity to BonT-A * Have been treated with BonT in the last 6 months. * Are diagnosed with myasthenia, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis * Have a known malignant condition * Have an ongoing infection in the area of injection * Are expecting to change their pain medication during the study period * Have been treated with topical agents such as capsaicin or lidocaine products in the affected areas for at least 3 months prior to inclusion * Are diagnosed with a competing cause of central or peripheral neuropathic pain, or other painful chronic conditions of the lower extremities, such as: * spinal stenosis * claudication * previous trauma or nerve injury * cancer related pain * Have a psychiatric condition that affects their completion of the study, as assessed by the investigator. * Are active abusers of alcohol or illegal substances * Are using or receiving treatment with cannabis products of any kind * Are pregnant or planning pregnancy during the study period * Score more than 12 on the Charlson Comorbidity Index

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Rigshospitalet Glostrup
Glostrup Municipality, Denmark

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05623111), the sponsor (Rigshospitalet, Denmark), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05623111 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05623111?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05623111?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05623111. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05623111. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.