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New shot could ease chronic heel pain

NCT ID NCT06169319

Symptom relief 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two doses of an injected biologic called EN3835 (collagenase) against a placebo in 231 adults with plantar fasciitis lasting at least 6 months. The goal was to see if it reduces daily heel pain and improves foot function over 12 weeks. Results are complete and will show whether this approach offers relief for people who haven't gotten better with standard treatments.

What this could mean

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

Active substance
Collagenase clostridium histolyticum (CCH) injection
What this could lead to
If it works, this could provide a new injection-based option to reduce heel pain and improve foot function for people with stubborn plantar fasciitis.
What could go wrong
This is a mid-stage trial with only 231 participants. The treatment may not prove more effective than placebo, and injections can cause local side effects like swelling or bruising.

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

231 people

The number who actually took part.

Started

Jan 2024

Finished

Sep 2024

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: * Have 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. * Have a diagnosis of plantar fasciitis for ≥6 months, which has not responded to conservative therapies. Conservative therapies may include rest, physical therapy, splinting/bracing, orthotics, icing, physiotherapy, acetaminophen, corticosteroids, or nonsteroidal anti-inflammatory drugs (NSAIDs). * Have current foot pain due to plantar fasciitis. Key Exclusion Criteria: * Has any musculoskeletal, neuromuscular, 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 a clinically meaningful laboratory abnormality. * Has a body mass index ≥35 kilograms per meter squared (kg/m\^2). * Has a known bleeding disorder, which, in the investigator's opinion, would make the participant unsuitable for enrollment in the study.

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Conditions

The condition(s) this trial relates to.

plantar fasciitis

As listed by the trial registrant

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

Plantar fasciitis

Contacts and locations

Locations

  • Endo Clinical Site 1

    Georgetown, Texas, 78628, United States

  • Endo Clinical Site 2

    Pasadena, Maryland, 21122, United States

  • Endo Clinical Site 3

    Pinellas Park, Florida, 33782, United States

  • Endo Clinical Site 4

    Bedford, Texas, 76021, United States

  • Endo Clinical Site 5

    Salt Lake City, Utah, 84107, United States

  • Endo Site 10

    Tarzana, California, 91356, United States

  • Endo Site 11

    Fresno, California, 93710, United States

  • Endo Site 12

    Suffolk, Virginia, 23434, United States

  • Endo Site 13

    Corona, California, 92882, United States

  • Endo Site 14

    Sweetwater, Florida, 33172, United States

  • Endo Site 15

    Houston, Texas, 77027, United States

  • Endo Site 16

    Los Angeles, California, 90010, United States

  • Endo Site 17

    Dallas, Texas, 75208, United States

  • Endo Site 18

    Dallas, Texas, 75251, United States

  • Endo Site 19

    Grand Rapids, Michigan, 49525, United States

  • Endo Site 20

    Castro Valley, California, 94546, United States

  • Endo Site 21

    San Francisco, California, 94115, United States

  • Endo Site 22

    San Antonio, Texas, 78258, United States

  • Endo Site 23

    Stonecrest, Georgia, 30038, United States

  • Endo Site 24

    Burleson, Texas, 76028, United States

  • Endo Site 25

    Moore, Oklahoma, 73160, United States

  • Endo Site 26

    Dallas, Texas, 75235, United States

  • Endo Site 27

    Missoula, Montana, 59804, United States

  • Endo Site 28

    O'Fallon, Illinois, 62269, United States

  • Endo Site 30

    Fort Worth, Texas, 76104, United States

  • Endo Site 31

    North Chicago, Illinois, 60064, United States

  • Endo Site 32

    Newport News, Virginia, 23606, United States

  • Endo Site 33

    Overland Park, Kansas, 66211, United States

  • Endo Site 34

    San Antonio, Texas, 78229, United States

  • Endo Site 35

    Shreveport, Louisiana, 71101, United States

  • Endo Site 36

    Malvern, Pennsylvania, 19355, United States

  • Endo Site 37

    Coconut Creek, Florida, 33073, United States

  • Endo Site 38

    Westwood, New Jersey, 07675, United States

  • Endo Site 39

    Portland, Oregon, 97202, United States

  • Endo Site 40

    Los Angeles, California, 90063, United States

  • Endo Site 6

    Encinitas, California, 92024, United States

  • Endo Site 7

    Lawrenceville, Georgia, 30043, United States

  • Endo Site 8

    Tucson, Arizona, 85712, United States

  • Endo Site 9

    McAllen, Texas, 78501, United States

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