Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New shot could ease pain of plantar fibromatosis

NCT ID NCT05152173

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an injection called EN3835 against a placebo in 176 people with plantar fibromatosis, a condition causing painful lumps on the soles of the feet. The goal was to see if EN3835 reduces foot pain and improves daily function over 57 days. Participants received up to two injections, and researchers measured pain and difficulty scores.

What this could mean

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

Active substance
EN3835 (a biologic injection)
What this could lead to
If it works, this could point toward a non-surgical treatment to ease foot pain and improve walking for people with plantar fibromatosis.
What could go wrong
This is an early Phase 2 trial with only 176 participants, so results may not apply to everyone. The treatment may not reduce pain better than placebo, and side effects 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

176 people

The number who actually took part.

Started

Nov 2021

Finished

Jan 2023

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 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: 1. Has a diagnosis of plantar fibromatosis AND have at least 1 measurable, hard or firm, palpable fibrous nodule on clinical examination. 2. Has no significant medical history or examination findings related to the participant's plantar nodule(s), which in the investigator's opinion, would make the participant unsuitable for study intervention administration. 3. Agree not to use opioids during the study period and has not used opioids 2 weeks before the Screening Visit. 4. Agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study period. 5. If female, be of non-childbearing potential (history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the Screening Visit); 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 any active treatment period. 6. Willing and able to comply with all protocol required visits and assessments. 7. Be adequately informed and understand the nature and risks of the study and be able to provide consent. Exclusion Criteria: 1. Has the presence of non-plantar fibromatosis-related nodules on the foot/feet (eg, neurofibroma, rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, or malignant soft tissue lesions of the foot or ankle). 2. Has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his or her feet and/or would impair his/her completion of study assessments as determined by the investigator. 3. Has a known allergy to collagenase or any other excipient of EN3835. 4. Has a known coagulation disorder or is taking any medications that would increase the risk of bleeding (except \<150mg of aspirin daily), 7 days prior to first injection and for the duration of the study. 5. Has concurrent diseases that might interfere with the conduct of the study, confound the interpretation of the study results or endanger the participant's well-being. If there is a history of such disease and the condition has been stable for greater than one year and is judged by the investigator not to interfere, the participant may be included, with the documented approval of the Medical Monitor. 6. Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the IRB/IEC. 7. Has any other condition(s) that, in the investigator's opinion, might indicate the participants to be unsuitable for the study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Plantar fibromatosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Fibromatosis, Plantar plantar fibromatosis

As listed by the trial registrant

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

Plantar fibromatosis

Contacts and locations

Locations

  • Endo Clinical Trial Site #1

    McAllen, Texas, 78501, United States

  • Endo Clinical Trial Site #10

    Pinellas Park, Florida, 33782, United States

  • Endo Clinical Trial Site #11

    Suffolk, Virginia, 23434, United States

  • Endo Clinical Trial Site #12

    Tarzana, California, 91356, United States

  • Endo Clinical Trial Site #13

    Whittier, California, 90603, United States

  • Endo Clinical Trial Site #14

    Sweetwater, Florida, 33172, United States

  • Endo Clinical Trial Site #15

    Bakersfield, California, 93311, United States

  • Endo Clinical Trial Site #16

    Atlantis, Florida, 33462, United States

  • Endo Clinical Trial Site #17

    Dallas, Texas, 75208, United States

  • Endo Clinical Trial Site #18

    Salt Lake City, Utah, 84107, United States

  • Endo Clinical Trial Site #19

    O'Fallon, Illinois, 62269, United States

  • Endo Clinical Trial Site #2

    Dallas, Texas, 75251, United States

  • Endo Clinical Trial Site #20

    Las Vegas, Nevada, 89119, United States

  • Endo Clinical Trial Site #21

    San Antonio, Texas, 78211, United States

  • Endo Clinical Trial Site #22

    Vista, California, 92083, United States

  • Endo Clinical Trial Site #23

    Pasadena, Maryland, 21122, United States

  • Endo Clinical Trial Site #24

    Cedar Park, Texas, 78613, United States

  • Endo Clinical Trial Site #25

    Houston, Texas, 77027, United States

  • Endo Clinical Trial Site #26

    Lynchburg, Virginia, 24501, United States

  • Endo Clinical Trial Site #27

    La Mesa, California, 91942, United States

  • Endo Clinical Trial Site #28

    Jefferson City, Missouri, 65109, United States

  • Endo Clinical Trial Site #29

    Mesa, Arizona, 85206, United States

  • Endo Clinical Trial Site #3

    South Miami, Florida, 33143, United States

  • Endo Clinical Trial Site #30

    Los Angeles, California, 90010, United States

  • Endo Clinical Trial Site #31

    Meridian, Idaho, 83642, United States

  • Endo Clinical Trial Site #32

    Decatur, Illinois, 62521, United States

  • Endo Clinical Trial Site #33

    Springfield, Illinois, 62704, United States

  • Endo Clinical Trial Site #34

    Oklahoma City, Oklahoma, 73109, United States

  • Endo Clinical Trial Site #35

    Arlington, Texas, 76015, United States

  • Endo Clinical Trial Site #36

    Torrance, California, 90502, United States

  • Endo Clinical Trial Site #37

    Midlothian, Virginia, 23114, United States

  • Endo Clinical Trial Site #38

    Lawrenceville, Georgia, 30043, United States

  • Endo Clinical Trial Site #39

    Georgetown, Texas, 78628, United States

  • Endo Clinical Trial Site #4

    York, Pennsylvania, 17402, United States

  • Endo Clinical Trial Site #40

    Miami, Florida, 33176, United States

  • Endo Clinical Trial Site #41

    Encinitas, California, 92024, United States

  • Endo Clinical Trial Site #42

    Tucson, Arizona, 85712, United States

  • Endo Clinical Trial Site #43

    Jacksonville, Florida, 32209, United States

  • Endo Clinical Trial Site #5

    Bedford, Texas, 76021, United States

  • Endo Clinical Trial Site #6

    San Antonio, Texas, 78229, United States

  • Endo Clinical Trial Site #7

    Fort Worth, Texas, 76104, United States

  • Endo Clinical Trial Site #8

    Houston, Texas, 77095, United States

  • Endo Clinical Trial Site #9

    Fresno, California, 93710, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.