Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

Study Overview
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Brief Summary
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Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis

Detailed Description
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Approximately 146 patients will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 12-month observation period. The study is expected to be completed within 36 months, inclusive of enrollment and follow-up of all subjects.

Official Title
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A Prospective, Single-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to the Saline Placebo Injection in the Treatment of Plantar Fasciitis

Conditions
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Fasciitis, Plantar

Intervention / Treatment
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* Other: AmnioFix® Injectable
* Drug: Saline Injection


Participation Criteria
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Eligibility Criteria
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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 Ability to sign Informed Consent and Release of Medical Information Forms 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 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 (Baxter Nerve Syndrome) Fat pad atrophy Acute traumatic rupture of the plantar fascia Calcaneal tumor Tarsal tunnel syndrome 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, such as Gentamicin sulfate or Streptomycin sulfate Clinically significant abnormal laboratory tests at baseline, including CBC, PT/PTT/INR, liver function and creatinine, as determined by the investigator Patients 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 patients

Ages Eligible for Study
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Minimum Age: 21 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AmnioFix® Injectable<br>1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM) | Other: AmnioFix® Injectable<br>* 1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)<br>* Other names: dHACM;|
| Placebo Comparator: Saline Injection<br>Injection of 1mL 0.9% Sodium Chloride Injection, USP | Drug: Saline Injection<br>* Injection of 1mL 0.9% Sodium Chloride Injection, USP<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 20% improvement over baseline Visual Analog Scale for Pain | Visual Analog Scale | 3 Months | 
| Incidence of adverse events | Review AE at every visit | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 20% improvement in Foot Function Index-Revised (FFI-R) score from baseline | Foot Function Index | 3 months | 
| Blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm | Lab blood draws | 3 and 12 months | 
| Long-term FFI-R outcomes | Foot Function Index | 6 and 12 months | 
| Long-term Visual Analog Scale (VAS) Pain outcomes | Visual Analog Scale | 6 and 12 months | 
| Long-term blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm | Lab blood draws | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heel pain, Chronic plantar fasciitis