Venous Leg UlcerNCT01552447
Human Amniotic Membrane Grafting and Standard of Care Versus Standard of Care Alone in the Treatment of Venous Leg Ulcers
A study testing EpiFix and Compression Therapy in people with Venous Leg Ulcer, run by MiMedx Group, Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of venous leg ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- EpiFix and Compression Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2012to May 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
- Ankle Brachial Pressure Index (ABI) > 0.75
- Presence of a venous leg ulcer extending through the full thickness of the skin but not down to muscle, tendon or bone
- Study ulcer has been present for at least one month prior to the initial screening visit, and is excluded if it has undergone 12 months of continuous high strength compression therapy over its duration
- Study ulcer is a minimum of 2 cm2 and a maximum of 20 cm2 at the Randomization visit
- The target ulcer has been treated with compression therapy for at least 14 days prior to randomization
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- Ulcer has a clean, granulating base with minimal adherent slough at the Randomization visit
- 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
- Study ulcer(s) deemed by the investigator to be caused by a medical condition other than venous insufficiency
- Study ulcer exhibits clinical signs and symptoms of infection.
- Non-mobile i.e. not ambulatory, or bed ridden
- Study ulcer, in the opinion of the investigator, is suspicious for cancer should undergo an ulcer biopsy to rule out a carcinoma of the ulcer
- Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface 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
- Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding Screening
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- History of radiation at the ulcer site
- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
- Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days
- Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the course of the trial.
- 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
- NYHA Class III and IV congestive heart failure (CHF), as defined by the following criteria: Class III: Symptoms with moderate exertion; Class IV: Symptoms at rest
- Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded.
- Pregnant or breast feeding
- Currently taking medications which could affect graft incorporation.(supervising physicians discretion)
- Allergic to gentamicin and streptomycin
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Eric J. Lullove DPM
Boca Raton, Florida, 33433
St. Vincent's Health Center
Erie, Pennsylvania, 16502
MetroWest Medical Center
Framingham, Massachusetts
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, 16201
St. Johns Wound Center
Tulsa, Oklahoma
About this study
Official title: A Multi-center Randomized Controlled Clinical Trial Evaluating Two Application Regimens of Human Amniotic Membrane Grafting and Standard of Care Versus Standard of Care Alone in the Treatment of Venous Leg Ulcers.
The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of venous leg ulcers.
- Conditions
- Venous Leg Ulcer
- Being tested
- EpiFix, Compression Therapy
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiFixOther
Dehydrated placental tissue
Compression TherapyOther
Compression bandaging
| Study group | Role | What they receive |
|---|---|---|
| 1 application of EpiFix | Other | 1 x dehydrated human amnion/chorion membrane Receives: Other: EpiFix; Other: Compression Therapy |
| 2 applications of EpiFix | Other | 2 x dehydrated human amnion/chorion membrane Receives: Other: EpiFix; Other: Compression Therapy |
| Standard of care | Other | Compression bandaging Receives: Other: Compression Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of wounds achieving 40% closure in patients treated with amniotic membrane vs. standard of care
Measured: 4 week
Secondary outcomes (3)
The proportion of wounds achieving 40% closure in patients treated with one application of amniotic membrane vs. standard of care
Measured: 4 week
The proportion of wounds achieving 40% closure in patients treated with one application of amniotic membrane vs. 2 applications of amniotic membrane
Measured: 4 week
The proportion of wounds achieving 40% closure in patients treated with two applications of amniotic membrane vs. standard of care
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies 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
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas E Serena, MD, Principal investigator, Penn North Centers for Advanced Wound Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552447
- Sponsor's protocol ID
- EFVLU001
- Status last verified
- Mar 2016
- First submitted
- 6 Mar 2012
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Controlled Clinical Trial Evaluating Two Application Regimens of Human Amniotic Membrane Grafting and Standard of Care Versus Standard of Care Alone in the Treatment of Venous Leg Ulcers.
- ClinicalTrials.gov ID
- NCT01552447
- Acronym / sponsor ID
- EFVLU001
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Mar 2012 (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 the EpiFix human amniotic membrane is effective in the treatment of venous leg ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 application of EpiFix | Other | Other: EpiFix, Other: Compression Therapy1 x dehydrated human amnion/chorion membrane |
| 2 applications of EpiFix | Other | Other: EpiFix, Other: Compression Therapy2 x dehydrated human amnion/chorion membrane |
| Standard of care | Other | Other: Compression TherapyCompression bandaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 18 years old
- Ankle Brachial Pressure Index (ABI) > 0.75
- Presence of a venous leg ulcer extending through the full thickness of the skin but not down to muscle, tendon or bone
- Study ulcer has been present for at least one month prior to the initial screening visit, and is excluded if it has undergone 12 months of continuous high strength compression therapy over its duration
- Study ulcer is a minimum of 2 cm2 and a maximum of 20 cm2 at the Randomization visit
Key exclusion criteria (17 listed)
- Study ulcer(s) deemed by the investigator to be caused by a medical condition other than venous insufficiency
- Study ulcer exhibits clinical signs and symptoms of infection.
- Non-mobile i.e. not ambulatory, or bed ridden
- Study ulcer, in the opinion of the investigator, is suspicious for cancer should undergo an ulcer biopsy to rule out a carcinoma of the ulcer
- Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface 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
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 |
|---|---|---|
| EpiFixDehydrated placental tissue | Other | 1 application of EpiFix, 2 applications of EpiFix |
| Compression TherapyCompression bandaging | Other | 1 application of EpiFix, 2 applications of EpiFix, Standard of care |
Primary outcome
The proportion of wounds achieving 40% closure in patients treated with amniotic membrane vs. standard of care
Time frame: 4 week
3 secondary outcomes
The proportion of wounds achieving 40% closure in patients treated with one application of amniotic membrane vs. standard of care
Time frame: 4 week
The proportion of wounds achieving 40% closure in patients treated with one application of amniotic membrane vs. 2 applications of amniotic membrane
Time frame: 4 week
The proportion of wounds achieving 40% closure in patients treated with two applications of amniotic membrane vs. standard of care
Time frame: 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
Thomas E Serena, MD principal investigator
Penn North Centers for Advanced Wound Care
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EpiFix and Compression Therapy in people with Venous Leg Ulcer, run by MiMedx Group, Inc. at 5 sites 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 10 inclusion and 17 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: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of wounds achieving 40% closure in patients treated with amniotic membrane vs. standard of care (time frame: 4 week). 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 16 Mar 2016.