Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Plantar Fasciitis

Prospective, double-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis

Approximately 276 patients will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 6-month observation period. Randomization will be 1:1. The study is expected to be completed within 34 months, inclusive of enrollment and follow-up of all subjects.

Inclusion Criteria:

1. Confirmed diagnosis of plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator

2. VAS Pain scale of ≥ 45 mm at randomization

3. Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities:

   • RICE
   • Stretching exercises
   • NSAIDs
   • Orthotics

4. Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities

5. BMI ≤ 40 kg/m2

6. Age ≥ 21 years and < 80 years

7. Ability to sign Informed Consent and Release of Medical Information Forms

8. Ability to receive and respond to text messages or emails on a daily basis.

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