ReNu™ vs. Corticosteroids for the Treatment of Plantar Fasciitis

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical trial is to evaluate both the safety and efficacy of the ReNu™ injection on pain and inflammation in subjects diagnosed with plantar fasciitis as compared to a Corticosteroid Injection which is considered standard of care.

Detailed Description
-----------------
This is a two (2) arm evaluation in 150 subjects with plantar fasciitis. Patients will be treated with ReNu™(study treatment) or Corticosteroids (control). At each follow-up visit, concomitant medications and adverse events shall be collected from each subject, and each subject shall complete following questionnaires: AOFAS Ankle-Hindfoot Score (AOFAS-AHS) Visual Analog Score (VAS) Single Answer Numeric Evaluation (SANE) Subject Satisfaction Score (at the 6 Month Follow Ups ONLY) The subjects will be assessed at Baseline (pre-injection) using these scales and again at all subsequent study follow-up visits.

Official Title
-----------------
A Comparative Study of Injectable Human Amniotic Allograft (ReNu™) Versus Corticosteroids for Plantar Fasciitis: A Prospective, Randomized, Blinded Study

Conditions
-----------------
Fasciitis, Plantar

Intervention / Treatment
-----------------
* Other: ReNu Injection
* Other: Corticosteroid Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 to 75 inclusive BMI less than 40 Actively practicing a contraception method, abstinent, surgically sterile, or post-menopausal (defined as no menses for a minimum of 12 months) Reporting heel pain of >6 on a verbally administered 1-10 pain scale where 1 is no pain and 10 is extreme pain Diagnosed with plantar fasciitis in either foot Completed a minimum of two months of conservative, non-injection treatment/therapies (i.e., activity modification, icing, NSAIDs, orthotics, physical therapy, etc.) Exclusion Criteria Prior surgery on the affected foot Prior injection treatment for plantar fasciitis within the past 6 months with steroids or tissue engineered materials just in the site seeking treatment Clinical signs and symptoms of infection of foot in question Evidence of significant neurological disease of either foot Non-ambulatory Presence of comorbidities that can be confused with or can exacerbate the condition including, but not limited to the following: Calcaneal stress fracture Nerve entrapment syndrome, such as Baxter's Nerve Entrapment or Tarsal Tunnel Syndrome Plantar Fascial rupture Systemic disorders associated with enthesiopathy, i.e., Gout, Reiter's syndrome, rheumatoid arthritis, etc. Achilles tendonitis Fat Pad Atrophy Fibromyalgia Diabetic Neuropathy Pregnant, pregnant within the past six (6) months, breast feeding and/or desire to become pregnant during the course of the study, as verified by urine pregnancy test within one week prior to injection. Has taken NSAID medication within the past 14 days, or other pain medication in the past day History of more than two (2) weeks treatment with immuno-suppressants, including systemic corticosteroids or cytotoxic chemotherapy within one month prior to initial screening, or has receive such medications during the screening period, or are anticipated to require such medications during the course of the study. Taking any investigational drug(s) or therapeutic device(s) within 30 days preceding screening History of radiation therapy of the affected foot Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV Involved in a Worker's Compensation Claim of any kind Unable to understand the objectives of the trial Presence of any condition(s) which, in the opinion of the investigator, would compromise the subject's ability to complete this study Having a known history of poor adherence with medical treatment. Express an unwillingness to receive human allograft tissue

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReNu Injection<br>Plantar Fascia injection with ReNu. ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid. | Other: ReNu Injection<br>* ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.<br>|
| Active Comparator: Corticosteroid Injection<br>Plantar Fascia injection with Corticosteroids. | Other: Corticosteroid Injection<br>* Corticosteroids are considered a standard of care for treatment of Plantar Fasciitis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AOFAS score from baseline |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VAS pain score from baseline |  | 6 months | 
| Change in SANE function score from baseline |  | 6 months | 
| Return to Normal Function between treatment groups | Assessed using questionnaire by the Principal Investigator (PI) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Plantar Fasciitis, Jogger's Heel, ReNu