Micronized Dehydrated Human Amniotic Membrane Suspension in the Treatment of Lateral Epicondylitis (NCT01921569) | Clinical Trial Compass
TerminatedNot Applicable
Micronized Dehydrated Human Amniotic Membrane Suspension in the Treatment of Lateral Epicondylitis
Stopped: Study closed by sponsor
United States5 participantsStarted 2013-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients achieving improvement in ASES elbow score in the dHACM treatment group vs the control group.