Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

Exclusion Criteria

• •1. Prior surgery or trauma to the affected site
• •2. Subjects requiring bilateral plantar fasciitis treatment at time of enrollment
• •3. Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months
• •4. Has diabetes either Type I or Type II.
• •5. Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.
• •6. The presence of diagnosed 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 (diagnosed as Baxter Nerve Syndrome)
• •* Fat pad atrophy
• •* 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
• •7. Affected site exhibits clinical signs and symptoms of infection
• •8. Known allergy or known sensitivity to Aminoglycosides
• •9. Subjects who are non-ambulatory
• •10. 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
• •11. Prior radiation at the site
• •12. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment
• •13. Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)
• •14. 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
• •15. 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)
• •16. Workers' compensation subjects