Micronized dHACM Injectable for the Treatment of Achille Tendonitis

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

Detailed Description
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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.

Official Title
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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

Conditions
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Tendonitis;Achilles

Intervention / Treatment
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* Biological: Micronized DHACM
* Drug: Saline Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria All subjects enrolled must meet all the following criteria: Confirmed diagnosis of Achilles tendonitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator VAS Pain scale of ≥ 45 at randomization 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 Diagnostic AP and lateral X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities BMI ≤ 40 kg/m2 Age from 21 to 80 years Ability to sign Informed Consent and Release of Medical Information Forms 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. Prior surgery to the affected site. Subjects requiring bilateral Achilles tendonitis treatment at time of enrollment Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months Has diabetes either Type I or Type II Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc. 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 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 Affected site exhibits clinical signs and symptoms of infection Known allergy or known sensitivity to Aminoglycosides Subjects who are non-ambulatory 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 Prior radiation at the site Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment Immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) or Lyme disease 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 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) Workers' compensation patients

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micronized DHACM<br>1mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM) | Biological: Micronized DHACM<br>* 1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM).<br>* Other names: dHACM;|
| Placebo Comparator: Saline Injection<br>Injection of 1mL 0.9% Sodium Chloride Injection, USP | Drug: Saline Injection<br>* Injection of 1mL 0.9% Sodium Chloride Injection, USP<br>* Other names: Sodium Chloride Injection, USP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VAS score | Visual Analog Scale, Left end point is No Pain. Right end point is worst pain imaginable | 90 days | 
| Incidence of adverse events | The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection | 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot Function Index Revised (FFI-R) (Short Form) | Subjects circle the number that correlates how bad their foot pain was in certain situation. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Achilles Tendonitis