Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the AmnioFix Injectable human amniotic membrane is effective in the treatment of recalcitrant plantar fasciitis.

Official Title
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A Prospective, Randomized, Blinded, Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Other: Marcaine
* Other: 0.5cc AmnioFix
* Other: 1.25cc AmnioFix
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old. Both male and female patients will be selected. Plantar fasciitis has been treated with conservative usual care for at least 8 weeks, including at least three of the following modalities RICE Corticosteroid injection Stretching exercises NSAIDs Orthotics Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence). Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen. Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken. Exclusion Criteria: Prior surgery at the site Site that exhibits clinical signs and symptoms of infection History of chronic plantar fasciitis of more than twelve months Evidence of significant neurological disease of the feet Non Ambulatory Patients The presence of comorbidities that can be confused with or can exacerbate the condition including: Calcaneal stress fracture Nerve entrapment syndrome (baxter nerve syndrome or tarsal tunnel) Plantar fascial rupture Systemic disorders associated with enthesiopathy such as Gout, Reiters syndrome, rheumatoid arthritis, etc. Achilles tendonitis Fat pad atrophy Fibromyalgia Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study. Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding Screening. History of radiation at the site. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV. Study foot has been previously treated with tissue engineered materials such as PRP within the last 30 days. Patients who are unable to understand the aims and objectives of the trial. Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment. Pregnant or breast feeding. No pregnancy within the past 6 months. Allergy to Gentamycin Streptomycin

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Initial injections of Marcaine and Saline (one each) | Other: Marcaine<br>* Injection of 2cc of Marcaine<br>Other: Saline<br>* Injection of 1.25cc of Saline<br>|
| Experimental: 0.5cc AmnioFix Injectable<br>Initial injections of Marcaine and 0.5cc AmnioFix (one each) | Other: Marcaine<br>* Injection of 2cc of Marcaine<br>Other: 0.5cc AmnioFix<br>* Injection of 0.5cc of AmnioFix Injectable<br>|
| Experimental: 1.25cc AmnioFix Injectable<br>Initial injections of Marcaine and 1.25cc AmnioFix (one each) | Other: Marcaine<br>* Injection of 2cc of Marcaine<br>Other: 1.25cc AmnioFix<br>* Injection of 1.25cc of AmnioFix Injectable<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in American Orthopaedic Foot and Ankle Society (AOFAS) Hind Foot Score at 8 Weeks |  | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return to normal activities |  | Up to 8 Weeks | 
| Pain scale |  | Weekly up to 8 Weeks |