- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03414255
Micronized dHACM Injectable for the Treatment of Achille Tendonitis
A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial Of The Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Achilles Tendonitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35205
- Central Research Associates
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Arizona
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Tucson, Arizona, United States, 85723
- Southern Arizona VA Health Care System
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California
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Carlsbad, California, United States, 92009
- ILD Research Center
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Los Angeles, California, United States, 90057
- Foot and Ankle Clinic
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Pismo Beach, California, United States, 93449
- Five Cities Foot Clinic
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Florida
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Miami, Florida, United States, 33125
- South Florida Veterans Affairs
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Miami, Florida, United States, 33143
- Doctors Research Network
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Georgia
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Buford, Georgia, United States, 30518
- Northside Podiatry
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Illinois
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Springfield, Illinois, United States, 62704
- Foot and Ankle Center of Illinois
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Nevada
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Las Vegas, Nevada, United States, 89119
- Advanced Foot & Ankle Center
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Pennsylvania
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Altoona, Pennsylvania, United States, 16602
- University Orthopedics Center
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Pittsburgh, Pennsylvania, United States, 15224
- West Penn Hospital
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Texas
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McAllen, Texas, United States, 78501
- Futuro Clinical Trials
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Virginia
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Virginia Beach, Virginia, United States, 23464
- Coastal Podiatry, Inc.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
All subjects enrolled must meet all the following criteria:
- Confirmed diagnosis of Achilles tendonitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator
- VAS Pain scale of ≥ 45 at randomization
Achilles Tendonitis with conservative treatment for ≥1 month (30 days) while under the direction of the healthcare provider, including any of the following modalities:
- Rest, Ice, Compression, Elevation (RICE)
- Stretching exercises
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
- Orthotics
- Diagnostic AP and lateral X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities
- BMI ≤ 40 kg/m2
- Age from 21 to 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 Any potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.
- Prior surgery to the affected site.
- Subjects requiring bilateral Achilles tendonitis 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
- Suspected partial thickness tear of the Achilles tendon, as assessed by the investigator
- Calcaneal tumor
- Tarsal tunnel syndrome (diagnosed)
- Significant bone deformity of the foot that may interfere with the study
The presence of diagnosed comorbidities that require surgery or are unlikely to improve - to be assessed by Investigator-including but not limited to:
- Nerve entrapment syndrome
- Acute traumatic rupture of the Achilles tendon
- Partial thickness tears of the Achilles Tendon
- 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 of treatment with immune-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 system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) or Lyme disease
- History of any conditions (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 patients
Study Plan
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 |
---|---|
PLACEBO_COMPARATOR: Saline Injection
Injection of 1mL 0.9% Sodium Chloride Injection, USP
|
Injection of 1mL 0.9% Sodium Chloride Injection, USP
Other Names:
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EXPERIMENTAL: Micronized DHACM
1mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM)
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1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM).
Other Names:
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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, Left end point is "No Pain".
Right end point is "worst pain imaginable"
|
90 days
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Incidence of adverse events
Time Frame: 365 days
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The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection
|
365 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot Function Index Revised (FFI-R) (Short Form)
Time Frame: 90 days
|
Subjects circle the number that correlates how bad their foot pain was in certain situation.
|
90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stuart D Miller, MD, MedStar Union Memorial Hospital Baltimore, MD
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIAT001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Tendonitis;Achilles
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University of DelawareActive, not recruitingAchilles Tendinopathy | Achillodynia | Achilles Tendon Pain | Achilles Tendonitis | Achilles DegenerationUnited States
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Philadelphia College of Osteopathic MedicineNot yet recruitingAchilles Tendinopathy | Achilles Tendon Pain | Achilles Tendonitis | Ankle StrainUnited States
-
OrthoCarolina Research Institute, Inc.CompletedChronic Insertional Achilles TendonitisUnited States
-
University of LahoreCompletedAchilles TendonitisPakistan
-
Aristotle University Of ThessalonikiGeneral Hospital of Naoussa; Private Orthopedics Practice P. SymeonidisEnrolling by invitationAchilles Tendon Rupture | Achilles Tendon Injury | Achilles Tendon SurgeryGreece
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University of CalgarySport Science Association of Alberta (SSAA)UnknownAchilles Tendinopathy | Achilles Tendon Enthesopathy | Mid-Portion Achilles Tendinopathy | Insertional Achilles Tendinopathy | Non-Insertional Achilles TendinopathyCanada
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University College, LondonUnknownTendinopathy | Achilles Tendinitis | Achilles Degeneration | Achilles Tendinitis, Right Leg | Achilles Tendon Thickening | Achilles Tendinitis, Left LegUnited Kingdom
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Henry Ford Health SystemRecruitingAchilles Tendon Rupture | Achilles Tendon SurgeryUnited States
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Universidad de GranadaNot yet recruiting
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Aarhus University HospitalEnrolling by invitationAchilles Tendon Rupture | Achilles Tendon InjuryDenmark
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National Taiwan University HospitalRecruitingOsteoarthritis (OA) of the KneeTaiwan
-
Odense University HospitalCompleted
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Kaiser PermanenteTerminatedLateral Epicondylitis | Tennis ElbowUnited States
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The Jerzy Kukuczka Academy of Physical Education...University of LuebeckCompleted
-
MiMedx Group, Inc.Completed
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Singapore General HospitalNot yet recruitingLateral Epicondylitis, Unspecified Elbow