- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03414268
Micronized dHACM Injectable for the Treatment of Plantar Fasciitis
May 18, 2022 updated by: MiMedx Group, Inc.
A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Plantar Fasciitis
Prospective, double-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Approximately 276 patients will be enrolled in this study.
Each patient will receive 1 injection and be evaluated for efficacy and safety during a 6-month observation period.
Randomization will be 1:1.
The study is expected to be completed within 34 months, inclusive of enrollment and follow-up of all subjects.
Study Type
Interventional
Enrollment (Actual)
208
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85723
- Southern Arizona VA Health Care System
-
-
California
-
Carlsbad, California, United States, 92009
- ILD Research Center
-
Carmichael, California, United States, 95608
- Center for Clinical Research
-
Fresno, California, United States, 93721
- Limb Preservation Platform, Inc.
-
La Mesa, California, United States, 91942
- Horizon Clinical Research
-
Los Angeles, California, United States, 90057
- Foot and Ankle Clinic
-
Pismo Beach, California, United States, 93449
- Five Cities Foot Clinic
-
-
Florida
-
Bay Pines, Florida, United States, 33744
- Bay Pines VA Healthcare System
-
Sarasota, Florida, United States, 34232
- Gulfcoast Research Institute, LLC
-
South Miami, Florida, United States, 33143
- Doctors Research Network
-
-
Maryland
-
Baltimore, Maryland, United States, 21218
- Union Podiatry
-
-
Nevada
-
Las Vegas, Nevada, United States, 89119
- Advanced Foot & Ankle Center
-
-
Pennsylvania
-
Altoona, Pennsylvania, United States, 16602
- University Orthopedics Center
-
State College, Pennsylvania, United States, 16801
- University Orthopedics Center
-
-
Texas
-
McAllen, Texas, United States, 78501
- Futuro Clinical Trials, LLC
-
San Antonio, Texas, United States, 78229
- Endeavor Clinical Trials
-
-
Virginia
-
Virginia Beach, Virginia, United States, 23464
- Coastal Podiatry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 79 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed diagnosis of plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator
- VAS Pain scale of ≥ 45 mm at randomization
Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities:
- RICE
- Stretching exercises
- NSAIDs
- Orthotics
- Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities
- BMI ≤ 40 kg/m2
- Age ≥ 21 years and < 80 years
- Ability to sign Informed Consent and Release of Medical Information Forms
- Ability to receive and respond to text messages or emails on a daily basis.
Exclusion Criteria:
- Prior surgery or trauma to the affected site
- Subjects requiring bilateral plantar fasciitis treatment at time of enrollment
- Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months
- Has diabetes either Type I or Type II.
- Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.
The presence of diagnosed comorbidities that can be confused with or can exacerbate the condition- to be assessed by X-ray - including but not limited to:
- Calcaneal stress fracture
- Nerve entrapment syndrome (diagnosed as Baxter Nerve Syndrome)
- Fat pad atrophy
- Acute traumatic rupture of the plantar fascia
- Calcaneal tumor
- Tarsal tunnel syndrome (diagnosed)
- Significant bone deformity of the foot that may interfere with the study
- Affected site exhibits clinical signs and symptoms of infection
- Known allergy or known sensitivity to Aminoglycosides
- Subjects who are non-ambulatory
- History of more than 14 days treatment with immuno-suppressants (including systemic corticosteroids) or cytotoxic chemotherapy within 30 days prior to enrollment, or who are anticipated to require such medications during the course of the study
- Prior radiation at the site
- Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment
- Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)
- History of any condition (including drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol, in the judgment of the investigator
- Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
- Workers' compensation subjects
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Micronized dHACM
1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)
|
1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)
Other Names:
|
PLACEBO_COMPARATOR: Saline Injection
Injection of 1mL 0.9% Sodium Chloride Injection, USP
|
Injection of 1mL 0.9% Sodium Chloride Injection, USP
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in VAS score
Time Frame: 90 Days
|
Visual Analog Scale for Pain:
|
90 Days
|
Incidence of adverse events
Time Frame: 180 Days
|
The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection
|
180 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot Function Index - Revised (FFI-R) (Short Form)
Time Frame: 90 Days
|
Foot Function Index - Revised: Patient Reported Questionnaire
|
90 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 8, 2018
Primary Completion (ACTUAL)
March 17, 2021
Study Completion (ACTUAL)
March 17, 2021
Study Registration Dates
First Submitted
January 23, 2018
First Submitted That Met QC Criteria
January 26, 2018
First Posted (ACTUAL)
January 29, 2018
Study Record Updates
Last Update Posted (ACTUAL)
May 19, 2022
Last Update Submitted That Met QC Criteria
May 18, 2022
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIPF007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fasciitis, Plantar
-
University of VirginiaNot yet recruitingPlantar Fascitis | Plantar Fasciopathy | Plantar Fasciitis, Chronic | Plantar Fasciitis of Both Feet | Plantar Fasciitis of Right Foot | Plantar Fasciitis of Left FootUnited States
-
Cairo UniversityNot yet recruiting
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...RecruitingPlantar FascitisItaly
-
Chinese University of Hong KongRecruiting
-
Istanbul Medeniyet UniversityNot yet recruiting
-
Chinese University of Hong KongRecruitingPlantar FascitisHong Kong
-
Stanford UniversityNot yet recruitingPlantar Fascitis
-
Hospital for Special Surgery, New YorkActive, not recruiting
-
Riphah International UniversityCompletedPlantar FascitisPakistan
-
Universidad Complutense de MadridUnknownPlantar Fasciitis | Ultrasound Therapy | Plantar Fasciitis, ChronicSpain
Clinical Trials on Saline Injection
-
The Catholic University of KoreaCompleted
-
Aalborg UniversityThe Danish Rheumatism AssociationCompleted
-
National Taiwan University HospitalRecruitingOsteoarthritis (OA) of the KneeTaiwan
-
New York Medical CollegeCompletedWrinkle | Nasolabial Fold | Skin Rejuvenation | Skin QualityUnited States
-
Odense University HospitalCompleted
-
Kaiser PermanenteTerminatedLateral Epicondylitis | Tennis ElbowUnited States
-
The Jerzy Kukuczka Academy of Physical Education...University of LuebeckCompleted
-
Singapore General HospitalNot yet recruitingLateral Epicondylitis, Unspecified Elbow
-
Tisch Multiple Sclerosis Research Center of New...CompletedMultiple SclerosisUnited States