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Could a single injection replace surgery for hammertoes?

NCT ID NCT07759362

Disease control Sponsor: Endo USA Inc., a Keenova Therapeutics Company Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This Phase 3 trial tests an injectable treatment called KN3835 against a placebo in about 554 people with flexible or semi-flexible hammertoes. The goal is to see if KN3835 can reduce the toe's bending and improve foot function and pain. Participants receive either the treatment or a placebo injection, and their progress is measured over about two months.

What this could mean

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

Active substance
KN3835, an injectable biological treatment
What this could lead to
If successful, KN3835 could offer a non-surgical way to correct flexible hammertoes and reduce foot pain and disability.
What could go wrong
This is an early-stage test in a large group, and results may not match real-world outcomes. Possible side effects include injection-site reactions or the treatment not working for everyone.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 554 people

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

Started

Aug 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 75 years

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.

Key Inclusion Criteria: * Has no significant medical history or examination findings related to the foot to be treated, which in the investigator's opinion, would make the participant unsuitable for study intervention administration or study required evaluations. * If female, be of non-childbearing potential or, if of childbearing potential, be non-pregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after treatment. * Be willing and able to comply with all protocol required visits and assessments. Key Exclusion Criteria: * Has any musculoskeletal, neurosensory, other neurological or related disorder that affects the participant's use of his/her feet and/or would impair his/her completion of study assessments as determined by the investigator either due to the disorder or due to pain. * Has any significant medical condition(s), which in the investigator's opinion would make the participant unsuitable for enrollment in the study. * Has previously participated in clinical studies of KN3835 for plantar fasciitis, plantar fibromatosis, or HMT. Note: Other inclusion/exclusion criteria may apply.

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As listed by the trial registrant

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

Flexible hammertoe Semi-flexible hammertoe

How to take part

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

  1. The places running it

    7 sites. 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

  • Keenova Site-002

    RECRUITING

    McAllen, Texas, 78501, United States

  • Keenova Site-003

    RECRUITING

    Bedford, Texas, 76021, United States

  • Keenova Site-004

    RECRUITING

    Pinellas Park, Florida, 33782, United States

  • Keenova Site-006

    RECRUITING

    Salt Lake City, Utah, 84107, United States

  • Keenova Site-007

    RECRUITING

    Sweetwater, Florida, 33172, United States

  • Keenova Site-008

    RECRUITING

    Tarzana, California, 91356, United States

  • Keenova Site-009

    RECRUITING

    Corona, California, 92882, United States