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Amnios™ RT Outcomes Study

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ClinicalTrials.gov Identifier: NCT04088383
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Globus Medical Inc

Brief Summary:
The purpose of this study is to evaluate clinical outcomes of patients with plantar fasciitis following treatment with Amnios™ RT. Patients will be randomized to either Amnios™ RT or a placebo control.

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Other: Amnios™ RT Other: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double Blind Investigation of Amnios™ RT for the Treatment of Plantar Fasciitis
Estimated Study Start Date : September 6, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Amnios™ RT Other: Amnios™ RT
Acellular human allograft

Placebo Comparator: Saline Other: Saline
Sterile saline




Primary Outcome Measures :
  1. Visual Analog Scale (VAS) Foot Pain Score [ Time Frame: 3 Months ]
    The visual analog scale (VAS) is a patient questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "most intense pain imaginable" on the right border. The subject is instructed to place a vertical line on the scale that indicates the pain severity experienced; 0mm is equal to no pain and 100mm is most intense pain imaginable. Study staff records the distance of the patient's mark on the scale in millimeters.

  2. Serious Adverse Events [ Time Frame: 12 Months ]
    The occurrence of serious adverse events that are related to the product.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of unilateral plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the Investigator
  • VAS Foot Pain score of at least 45mm (out of 100mm scale) at randomization
  • Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities:

    • RICE
    • Stretching exercises
    • NSAIDs
    • Orthotics
  • Diagnostic radiograph within 6 months of enrollment showing view of calcaneus, without evidence of calcaneal fracture or structural abnormalities
  • BMI ≤ 40 kg/m2
  • Age ≥ 18 years and < 80 years
  • Willing and able to comply with the follow-up requirements of the protocol
  • Signed an Informed Consent Form specific to this research and agreed to release of medical information

Exclusion Criteria:

  • Prior surgery or trauma resulting in severe, permanent damage to the affected foot
  • Require bilateral plantar fasciitis treatment at time of enrollment (with exception of compensatory symptoms on the non-affected foot)
  • Prior use of any lower limb injection therapy, including corticosteroids or PRP in either foot within the last 3 months
  • Has Type I or Type II diabetes mellitus
  • Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, reactive arthritis, rheumatoid arthritis, etc.
  • The presence of diagnosed comorbidities that can be confused with or can exacerbate the condition (as assessed by radiograph) including:

    • Calcaneal stress fracture
    • Nerve entrapment syndrome (diagnosed as Baxter Nerve Syndrome)
    • Fat pad atrophy (relative to expectations for patient's age)
    • 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
    • Other malignant tumors in the foot or conditions that may affect study outcomes
  • Affected site exhibits clinical signs and symptoms of infection of the foot in question
  • Known allergy or known sensitivity to aminoglycosides
  • Non-ambulatory
  • History of more than 14 days of 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, with exception of diagnostic radiographs
  • Use of any investigational drug(s) or investigational 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)
  • Prisoner

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088383


Contacts
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Contact: Jacqueline Myer 610-930-1800 jmyer@globusmedical.com

Locations
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United States, Texas
Bio-X-Cell Research Recruiting
San Antonio, Texas, United States, 78229
Contact: Myriam Cornell         
Sponsors and Collaborators
Globus Medical Inc

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Responsible Party: Globus Medical Inc
ClinicalTrials.gov Identifier: NCT04088383     History of Changes
Other Study ID Numbers: Rev0
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases