Amnios™ RT Outcomes Study

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Double Blind Investigation of Amnios™ RT for the Treatment of Plantar Fasciitis

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Other: Amnios™ RT
* Other: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Amnios™ RT<br> | Other: Amnios™ RT<br>* Acellular human allograft<br>|
| Placebo Comparator: Saline<br> | Other: Saline<br>* Sterile saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Foot Pain Score | 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. | 3 Months | 
| Serious Adverse Events | The occurrence of serious adverse events that are related to the product. | 12 Months |