Could Botox-Like shots ease diabetic foot pain?
NCT ID NCT05623111
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Rigshospitalet Glostrup
RECRUITINGGlostrup Municipality, 2600, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Electric pulses may bring back lost foot sensation in diabetes
- Spinal implant offers new hope for diabetic leg pain
- Foot exercises show promise for diabetic nerve pain relief
- Gene therapy shot aimed at diabetic nerve pain put to the test
- Gene therapy shot aims to ease diabetic foot pain
- Engensis pain treatment checked for Long-Term safety