Epicondylitis, Lateral HumeralNCT01921569
Micronized Dehydrated Human Amniotic Membrane Suspension in the Treatment of Lateral Epicondylitis
A study testing dHACM Injection and Normal Saline Injection in people with Epicondylitis, Lateral Humeral, run by MiMedx Group, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epicondylitis, Lateral Humeral
- What is being tested?
- dHACM Injection and Normal Saline Injection
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Beacon Orthopaedics & Sports Medicine
Sharonville, Ohio, 45241
About this study
Official title: Micronized Dehydrated Human Amniotic Membrane (dHACM) Suspension in the Treatment of Lateral Epicondylitis.
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.
- Conditions
- Epicondylitis, Lateral Humeral
- Being tested
- Standard of Care Therapy, dHACM Injection, Normal Saline Injection
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care TherapyBehavioural
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.
dHACM InjectionOther
Injection into affected area with micronized dHACM suspended with total volume of 1 cc normal saline.
Normal Saline InjectionOther
Injection into affected area with 1.0 cc normal saline solution instead of active agent.
| Study group | Role | What they receive |
|---|---|---|
| dHACM | Experimental | 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. Receives: Behavioral: Standard of Care Therapy; Other: dHACM Injection |
| Saline Injection | Placebo comparator | 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. Receives: Behavioral: Standard of Care Therapy; Other: Normal Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving improvement in ASES elbow score in the dHACM treatment group vs the control group.
Measured: 12 weeks
Secondary outcomes (1)
Proportion of patients achieving improvement in range of motion in the dHACM treatment group vs the control group.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Study closed by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicondylitis, Lateral HumeralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Kremchek, MD, Principal investigator, Beacon Orthopaedics & Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921569
- Sponsor's protocol ID
- AFLATEP001
- Status last verified
- Sep 2015
- First submitted
- 18 Jul 2013
- Last updated
- 24 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micronized Dehydrated Human Amniotic Membrane (dHACM) Suspension in the Treatment of Lateral Epicondylitis.
- ClinicalTrials.gov ID
- NCT01921569
- Acronym / sponsor ID
- AFLATEP001
- Conditions
- Epicondylitis, Lateral Humeral
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed by sponsor
- Enrolment
- 5 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dHACM | Experimental | Behavioral: Standard of Care Therapy, Other: dHACM InjectionStandard 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. |
| Saline Injection | Placebo comparator | Behavioral: Standard of Care Therapy, Other: Normal Saline InjectionStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care TherapyRest, ice, compression, elevation (RICE), NSAID or salicylate medication for pain, Physical Therapy and stretching exercises, Reduction in impact activities, to include an arm sling. | Behavioural | Saline Injection, dHACM |
| dHACM InjectionInjection into affected area with micronized dHACM suspended with total volume of 1 cc normal saline. | Other | dHACM |
| Normal Saline InjectionInjection into affected area with 1.0 cc normal saline solution instead of active agent. | Other | Saline Injection |
Primary outcome
Proportion of patients achieving improvement in ASES elbow score in the dHACM treatment group vs the control group.
Time frame: 12 weeks
1 secondary outcome
Proportion of patients achieving improvement in range of motion in the dHACM treatment group vs the control group.
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Study closed by sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Kremchek, MD principal investigator
Beacon Orthopaedics & Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dHACM Injection and Normal Saline Injection in people with Epicondylitis, Lateral Humeral, run by MiMedx Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study closed by sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving improvement in ASES elbow score in the dHACM treatment group vs the control group. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.