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Could Botox-Like shots ease diabetic foot pain?

NCT ID NCT05623111

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether injecting a botulinum toxin (similar to Botox) around nerves in the lower legs can safely reduce pain from diabetic neuropathy. About 80 adults with diabetes and chronic foot pain will receive either the active drug or a placebo injection every 12 weeks for 24 weeks. Researchers will track pain levels, quality of life, and any side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Incobotulinumtoxin-A (a type of botulinum toxin, like Botox)
What this could lead to
If it works, this could offer a new way to manage chronic diabetic nerve pain without strong painkillers.
What could go wrong
This is an early phase 2 trial with only 80 people, so results may not apply to everyone. The treatment involves injections every 12 weeks, and side effects or lack of effect are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rigshospitalet Glostrup

    RECRUITING

    Glostrup Municipality, 2600, Denmark

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