Micronized dHACM Injectable for the Treatment of Achille Tendonitis

A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial Of The Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Achilles Tendonitis

Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis

Approximately 158 subjects 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. Randomization will be 1:1. The study is expected to be completed in 24 months, inclusive of enrollment and follow-up of all subjects.

Inclusion Criteria

All subjects enrolled must meet all the following criteria:

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

2. VAS Pain scale of ≥ 45 at randomization

3. Achilles Tendonitis with conservative treatment for ≥1 month (30 days) while under the direction of the healthcare provider, including any of the following modalities:

   • Rest, Ice, Compression, Elevation (RICE)
   • Stretching exercises
   • Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
   • Orthotics

4. Diagnostic AP and lateral 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 from 21 to 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 Any potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.

1. Prior surgery to the affected site.

2. Subjects requiring bilateral Achilles tendonitis 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
   • Suspected partial thickness tear of the Achilles tendon, as assessed by the investigator
   • Calcaneal tumor
   • Tarsal tunnel syndrome (diagnosed)
   • Significant bone deformity of the foot that may interfere with the study

7. The presence of diagnosed comorbidities that require surgery or are unlikely to improve - to be assessed by Investigator-including but not limited to:

   • Nerve entrapment syndrome
   • Acute traumatic rupture of the Achilles tendon
   • Partial thickness tears of the Achilles Tendon

8. Affected site exhibits clinical signs and symptoms of infection

9. Known allergy or known sensitivity to Aminoglycosides

10. Subjects who are non-ambulatory

11. History of more than 14 days of treatment with immune-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

12. Prior radiation at the site

13. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment

14. Immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) or Lyme disease

15. History of any conditions (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

16. 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)

17. Workers' compensation patients