Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis

Study Overview
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Brief Summary
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This is a prospective, controlled, randomized, blinded and comparative, single-center clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis symptoms that have received standard of care versus treatment with differing amounts of injectable dehydrated human amnion/chorion membrane micrografts(dHACM).

Official Title
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A Prospective, Randomized, Controlled, Blinded, Comparative Study of Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Procedure: Injection of 1.0 cc of 0.9% Saline
* Procedure: Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension
* Procedure: Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension
* Procedure: Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension


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 Rest, Ice, Compression, Elevation (RICE) Corticosteroid injection Stretching exercises Non-steroidal Anti-Inflammatory Drugs (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's Nerve Entrapment or Tarsal Tunnel Syndrome) Plantar fascial rupture Systemic disorders associated with enthesiopathy (such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.) Achilles tendonitis Fat pad atrophy Fibromyalgia Diabetics with neuropathy 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 therapy at the site. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV. Study foot has been previously treated with tissue engineered materials 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 Gentamicin and/or 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: • Group 2:<br>Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension | Procedure: Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension<br>* Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension into affected area<br>|
| Experimental: • Group 3:<br>Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension | Procedure: Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension<br>* Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension into affected area<br>|
| Experimental: • Group 4:<br>Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension | Procedure: Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension<br>* Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension into affected area<br>|
| Placebo Comparator: • Group 1<br>• Injection of 1.0 cc of 0.9% Saline | Procedure: Injection of 1.0 cc of 0.9% Saline<br>* Injection of 1.0 cc of 0.9% Saline into affected area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of inflammation as measured by AOFAS Hindfoot scores | The primary objective of this study is to compare the efficacy of the different treatment amounts in reduction of inflammation as measured by AOFAS Hindfoot scores. | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to normal activities more quickly than with standard of care | The secondary objective is to demonstrate that patients treated with micronized dHACM injectable will return to normal activities more quickly than with standard of care. | 8 Weeks | 
| Pain as measured by 0-10 Numeric Rating Scale | Patient pain scores will be assessed between all groups. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plantar fasciitis