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A Study to Assess Collagenase Clostridium Histolyticum (CCH) in the Treatment of Plantar Fasciitis (PFA) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Assess Collagenase Clostridium Histolyticum (CCH) in the Treatment of Plantar Fasciitis (PFA)

A Phase 2, Double-blind, Randomized, Placebo-controlled, Dose-ranging Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fasciitis (PFA)

NCT06169319•Endo Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will assess the efficacy, safety, and tolerability of 2 different doses of collagenase clostridium histolyticum (CCH) (previously known as EN3835) compared to placebo.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

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.

Locations (39)

Endo Site 8

Tucson, Arizona, United States

Endo Site 20

Castro Valley, California, United States

Endo Site 13

Corona, California, United States

Endo Site 6

Encinitas, California, United States

Endo Site 11

Fresno, California, United States

Endo Site 16

Los Angeles, California, United States

Endo Site 40

Los Angeles, California, United States

Endo Site 21

San Francisco, California, United States

Endo Site 10

Tarzana, California, United States

Endo Site 37

Coconut Creek, Florida, United States

Key Dates

Start Date

January 3, 2024

Primary Completion Date

September 30, 2024

Completion Date

September 30, 2024

Last Updated

September 30, 2025

Enrollment

231

ACTUAL participants

Conditions

Plantar Fasciitis

Interventions

Collagenase Clostridium Histolyticum (CCH)

BIOLOGICAL

Placebo

BIOLOGICAL

Effect of Additional Sural Nerve PRF in Chronic Heel Pain

NCT07383558

Chronic Plantar Heel PainPlantar Fasciitis+1 more

View study

RECRUITINGNA

Percutaneous Electrolysis Targeting the Muscle-Fascia Chain for Treating Chronic Plantar Fasciitis in Adults

NCT07294196

Plantar Fasciitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess Collagenase Clostridium Histolyticum (CCH) in the Treatment of Plantar Fasciitis (PFA)

Inclusion Criteria

Exclusion Criteria

Effect of Additional Sural Nerve PRF in Chronic Heel Pain

Percutaneous Electrolysis Targeting the Muscle-Fascia Chain for Treating Chronic Plantar Fasciitis in Adults

Acupuncture of Different Treatment Frequency in Chronic Plantar Fasciitis

Temporal Differences in Pain, Muscle Stiffness, and Function in Subjects With Plantar Fasciitis After Myofascial Release Therapy

A Novel Approach to Plantar Fasciitis in the Aging Population

Anthropometric Parameters of the Foot and Plantar Fasciitis