Leg UlcerNCT02011503
Use of dHACM in the Treatment of Venous Leg Ulcers
A study testing Multi-layer compression therapy and Application of dHACM in people with Leg Ulcer, run by MiMedx Group, Inc. at 15 sites in United States.
Trial summary
The overall objective of this study is to evaluate the effectiveness of dehydrated human amnion/ chorion membrane (dHACM) in reducing time to complete wound closure in patients with venous leg ulcers (VLUs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcer
- What is being tested?
- Multi-layer compression therapy and Application of dHACM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 15 sitesUnited States
- Study dates
- Mar 2014to 30 Nov 2017
- 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
- Index ulcer characteristics:
- Full-thickness venous leg ulcer for ≥ 30 days
- Ulcer area after debridement is ≥ 1 cm² and ≤ 25 cm² at the randomization visit
- Has a clean, granulating base with minimal adherent slough
- Subject has completed 14 day run-in period with ≤ 25% wound area reduction post-debridement.
- Have one of the following:
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- Ankle Brachial Pressure Index (ABI) > 0.75. (Calculations will be made using measurements from both posterior tibial and dorsalis pedis arteries as well as both arms) OR
- Have venous insufficiency confirmed by duplex ultrasound examination for valvular or venous incompetence.
- Age ≥ 18.
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- Ability to read/understand and sign Informed Consent and Release of Medical Information Forms.
- Ability to understand and comply with weekly visits and follow-up regimen.
Who cannot join
- Index Ulcer Assessment - Index ulcer meeting the following criteria will not be eligible for enrollment:
- Penetrates down to muscle, tendon, or bone
- Presence of another venous ulcer ≤ 2 cm from index ulcer
- Is deemed by the Investigator to be caused by a medical condition other than venous insufficiency
- Exhibits clinical signs and symptoms of infection
- If in the opinion of the Investigator, the wound is suspicious for cancer, the subject should undergo an ulcer biopsy to rule out carcinoma. If carcinoma is ruled out, the subject may be re-screened.
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- Located on the dorsum of the foot or with more than 50% of the ulcer below the malleolus
- Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:
- In the last 7 days - Negative pressure wound therapy of the index ulcer
- In the last 7 days - Hyperbaric oxygen therapy
- In the last 30 days - Treatment with cytotoxic chemotherapy, application of topical steroids to the ulcer surface, or use of ≥ 14 days of immune-suppressants (including systemic corticosteroids); or, subject is anticipated to require such medications during the course of the study
- In the last 30 days - study ulcer treatment with any advanced therapy, including EpiFix®, tissue engineered materials (e.g. Apligraf® or Dermagraft®), or other scaffold materials (e.g. OASIS® Wound Matrix, MatriStem® Wound Matrix)
- In the last 30 days - Subject has been on any investigational drug(s) or therapeutic device(s)
- In the last 8 weeks - Amputation or revascularization (surgical or stenting) to the affected leg
- Any history of radiation at the ulcer site
- Any prior participation in a MiMedx® study
- Study ulcer has undergone ≥ 12 months of continuous high strength compression therapy over its duration
- Subject criteria that will make subject ineligible for enrollment:
- Known osteomyelitis or active cellulitis at wound site
- Hemoglobin A1C >12 in the last 60 days prior to randomization
- Active malignant disease or subject is less than 1 year disease-free
- 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
- Auto-immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV
- Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
- Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate MLCT
- Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator
- Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
VA Western New York Health Care System
Buffalo, New York, 14215
ILD Research
Carlsbad, California, 92009
Center for Clinical Research, Inc.
Castro Valley, California, 94546
William Jennings Bryan Dorn Veterans Affairs Medical Center
Columbia, South Carolina, 29209
Atlanta Veteran's Administration
Decatur, Georgia, 30033
Center for Clinical Research, Inc.
Eugene, Oregon, 97401
Center for Clinical Research, Inc.
Fair Oaks, California, 95628
Limb Preservation Platform, Inc.
Fresno, California, 93720
Hackensack University Medical Center
Hackensack, New Jersey, 07601
SGM Physicians
Haverford, Pennsylvania, 19041
VA Loma Linda Healthcare System
Loma Linda, California, 92357
VA Northern California
Mather, California, 95655
Associated Foot & Ankle Specialists, PC
Phoenix, Arizona, 85015
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212
Center for Clinical Research, Inc.
San Francisco, California, 94115
About this study
Official title: A Randomized Controlled Clinical Trial Evaluating The Application Of Dehydrated Human Amnion/ Chorion Membrane (dHACM) Plus Standard Of Care Vs. Standard Of Care Alone In The Treatment Of Venous Leg Ulcers
The overall objective of this study is to evaluate the effectiveness of dehydrated human amnion/ chorion membrane (dHACM) in reducing time to complete wound closure in patients with venous leg ulcers (VLUs).
- Conditions
- Leg Ulcer
- Being tested
- Multi-layer compression therapy, Application of dHACM
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-layer compression therapyProcedure or surgery
Application of multi-layer compression therapy.
Application of dHACMOther
Application of dHACM to ulcer.
| Study group | Role | What they receive |
|---|---|---|
| dHACM | Experimental | Application of multi-layer compression therapy with application of dHACM. Receives: Procedure: Multi-layer compression therapy; Other: Application of dHACM |
| Control | Other | Application of multi-layer compression therapy without application of dHACM. Receives: Procedure: Multi-layer compression therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to 100% epithelialization of study ulcer
Measured: 12 weeks
Secondary outcomes (1)
Proportion of patients in both groups with complete wound healing at 12 weeks
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 Dec 2013 (estimated)
- Study startMar 2014
- Primary completion5 Aug 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Don Fetterolf, MD, Study director, MiMedx Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011503
- Sponsor's protocol ID
- EFVLU003
- Status last verified
- Aug 2018
- First submitted
- 21 Nov 2013
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial Evaluating The Application Of Dehydrated Human Amnion/ Chorion Membrane (dHACM) Plus Standard Of Care Vs. Standard Of Care Alone In The Treatment Of Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT02011503
- Acronym / sponsor ID
- EFVLU003
- Conditions
- Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- 5 Aug 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 13 Dec 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 overall objective of this study is to evaluate the effectiveness of dehydrated human amnion/ chorion membrane (dHACM) in reducing time to complete wound closure in patients with venous leg ulcers (VLUs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dHACM | Experimental | Procedure: Multi-layer compression therapy, Other: Application of dHACMApplication of multi-layer compression therapy with application of dHACM. |
| Control | Other | Procedure: Multi-layer compression therapyApplication of multi-layer compression therapy without application of dHACM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Index ulcer characteristics:
- Subject has completed 14 day run-in period with ≤ 25% wound area reduction post-debridement.
- Have one of the following:
- Age ≥ 18.
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
Key exclusion criteria (27 listed)
- Index Ulcer Assessment - Index ulcer meeting the following criteria will not be eligible for enrollment:
- Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:
- Subject criteria that will make subject ineligible for enrollment:
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 |
|---|---|---|
| Multi-layer compression therapyApplication of multi-layer compression therapy. | Procedure or surgery | Control, dHACM |
| Application of dHACMApplication of dHACM to ulcer. | Other | dHACM |
Primary outcome
Time to 100% epithelialization of study ulcer
Time frame: 12 weeks
1 secondary outcome
Proportion of patients in both groups with complete wound healing at 12 weeks
Time frame: 12 weeks
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 24 Aug 2018.
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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.
Don Fetterolf, MD study director
MiMedx Group, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-layer compression therapy and Application of dHACM in people with Leg Ulcer, run by MiMedx Group, Inc. at 15 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 12 inclusion and 27 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 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Time to 100% epithelialization of study ulcer (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 Aug 2018.