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

MiMedx

Status: Terminated

Conditions: Epicondylitis, Lateral Humeral

Treatments: Other: dHACM Injection; Other: Normal Saline Injection; Behavioral: Standard of Care Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01921569

AFLATEP001

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups, including a placebo group

dHACM

Experimental group

Description:

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.

Treatment:

Behavioral: Standard of Care Therapy

Other: dHACM Injection

Saline Injection

Placebo Comparator group

Description:

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.

Treatment:

Other: Normal Saline Injection

Behavioral: Standard of Care Therapy