Micronized Dehydrated Human Amniotic Membrane Suspension in the Treatment of Lateral Epicondylitis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether micronized dehydrated human amniotic membrane (dHACM) suspension is more effective in reducing inflammation than conservative measures alone when used to treat acute/early lateral epicondylitis.

Official Title
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Micronized Dehydrated Human Amniotic Membrane (dHACM) Suspension in the Treatment of Lateral Epicondylitis.

Conditions
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Epicondylitis, Lateral Humeral

Intervention / Treatment
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* Behavioral: Standard of Care Therapy
* Other: dHACM Injection
* Other: Normal Saline Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old. Medicare patients may be selected. Both male and female patients will be selected. A negative x-ray of the elbow Diagnosis of lateral epicondylitis by history and exam with symptoms for no longer than one year. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence). Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen. Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken. Exclusion Criteria: Prior surgery at the site Site exhibits clinical signs and symptoms of infection. History of chronic soft tissue inflammation of more than 6 months. A positive X-ray for fracture or significant anatomic abnormality including fracture, advanced arthritis, excessive calcification, etc. No history of corticosteroid injection within the past 30 days. Joint instability No rheumatologic conditions involving the elbow. No evidence of significant neurological entrapment or neurological disease of the forearm Concurrent cervical radiculopathy The presence of comorbidities that can be confused with or can exacerbate the condition including: Previous elbow trauma Previous elbow surgery Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study. (i.e. a one month washout period for these drugs.) Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening. History of radiation at the site. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV. Patients who are unable to understand the aims and objectives of the trial. Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment. Pregnant or breast feeding. No pregnancy within the past 6 months.

Ages Eligible for Study
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Minimum Age: 18 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: dHACM<br>Standard of Care Therapy plus dHACM injection at initial visit, to be repeated if symptoms persist at the time of week 4 and week 8 follow up visits. | Behavioral: Standard of Care Therapy<br>* Rest, ice, compression, elevation (RICE), NSAID or salicylate medication for pain, Physical Therapy and stretching exercises, Reduction in impact activities, to include an arm sling.<br>Other: dHACM Injection<br>* Injection into affected area with micronized dHACM suspended with total volume of 1 cc normal saline.<br>|
| Placebo Comparator: Saline Injection<br>Standard of Care Therapy plus normal saline injection instead of active agent at initial visit, to be repeated if symptoms persist at the time of week 4 and week 8 follow up visits. | Behavioral: Standard of Care Therapy<br>* Rest, ice, compression, elevation (RICE), NSAID or salicylate medication for pain, Physical Therapy and stretching exercises, Reduction in impact activities, to include an arm sling.<br>Other: Normal Saline Injection<br>* Injection into affected area with 1.0 cc normal saline solution instead of active agent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving improvement in ASES elbow score in the dHACM treatment group vs the control group. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving improvement in range of motion in the dHACM treatment group vs the control group. |  | 12 weeks |