Venous Leg UlcersNCT02609594
Amnioband and Standard of Care vs. Standard of Care Alone in the Treatment of Venous Leg Ulcers
A study testing Weekly application of Amnioband and Biweekly application of Amnioband in people with Venous Leg Ulcers, run by SerenaGroup, Inc. at 8 sites in United States.
Trial summary
Lower extremity ulcers pose significant clinical, humanistic and economic burdens on society. Millions of Americans are afflicted with painful, open, draining sores on their lower extremities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcers
- What is being tested?
- Weekly application of Amnioband and Biweekly application of Amnioband
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2015to Dec 2018
- 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 OR SPP > 30 mmHg OR TCOM > 30 mmHg.*
- Presence of a venous leg ulcer extending through the full thickness of the skin but not down to muscle, tendon or bone.
- The largest ulcer will be designated the index ulcer and the only one included in the study. If other ulcerations are present on the same leg they have to be more than 2 cm apart from the index ulcer.
- Study ulcer (i.e. current episode of ulceration) has been present for greater than one month prior to the initial screening visit, and has failed to respond to documented conservative measures for greater than (1) one month duration 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.
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- The target ulcer has been treated with compression therapy for at least 14 days prior to randomization.
- 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).
- Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
- Subject 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.
- Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
- 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.
- Subjects with a history of more than two weeks treatment with immunosuppressants (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.
- Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding Screening.
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- Study ulcer improving greater than 30% during the screening phase if the subject was not in adequate compression 14 days prior to screening.
- History of drug or alcohol abuse.
- History of radiation at the ulcer site.
- Presence of one or more medical conditions, as determined by medical history, hematologic, active auto-immune or immune diseases that, in the opinion of the Investigator, would make the subject an inappropriate candidate for this ulcer healing study.
- 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.
- 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.
- Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded.
- Pregnant or breast feeding.
- Presence of diabetes with poor metabolic control as documented with a HgA1c > 12.0 within last 90 days
- Patients with renal dysfunction whose serum creatinine levels are 3.0mg/dl or greater within the last 90 days
- History of usage of tobacco products within the last 30 days
- History of Liver disease with active Cirrhosis of the liver
Trial locations and contacts
8 sites in 1 country.
Heather Connell, CCRP contact
8 sites in 1 country
United States8 sites, 6 recruiting
- Recruiting
Brigham and Women's Hospital Wound Care Center
Boston, Massachusetts, 02115
Laurie Bayer, PA-C, 617-732-8743
Indranil Sinha, MD
- Recruiting
Premier Surgical
Brick, New Jersey, 08723
Jarrod Kaufman, MD, 732-262-1600
- Completed
Inspira Medical Center - Elmer Wound Care Center
Elmer, New Jersey, 08318
- Recruiting
The Foot and Ankle Wellness Center
Ford City, Pennsylvania, 16226
Matthew Sabo, DPM, 724-763-4080
- Recruiting
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, 16201
Keyur Patel, MD, 724-543-8893
- Recruiting
Martinsville Research Institute
Martinsville, Virginia, 24112
Kim Young, 540-676-5886
Nathan Young, DPM
- Recruiting
SerenaGroup Research Institute
Pittsburgh, Pennsylvania, 15222
Thomas Serena, MD, 814-688-4000
- Completed
St John Medical Center
Tulsa, Oklahoma, 74135
About this study
Official title: A Multi-center Randomized Controlled Clinical Trial Evaluating Two Application Regimens of Amnioband Dehydrated Human Amniotic Membrane and Standard of Care vs. Standard of Care Alone in the Treatment of Venous Leg Ulcers
Lower extremity ulcers pose significant clinical, humanistic and economic burdens on society. Millions of Americans are afflicted with painful, open, draining sores on their lower extremities. These sores are referred to as venous leg ulcerations (VLUs).1-5 Under the best of circumstances these ulcers require weeks or months to heal. Not uncommonly wound care specialists see patients who have suffered for years or faced amputation of the limb as their only option to alleviate the pain.
Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However, roughly half of patients suffering from venous ulcers will require advanced therapy. Human amniotic membrane replaces the damaged extracellular matrix characteristic of chronic ulcers. In addition, it contains cytokines that may accelerate healing. In clinical practice and recent studies, Dehydrated Human Amniotic Membrane has appeared to be as effective as bioengineered skin products. This RCT is designed to evaluate Amnioband Dehydrated Human Amniotic Membrane in venous leg ulcers.
Read the detailed description
This study is a multi-center, randomized, trial designed to evaluate the safety and effectiveness of Amnioband Dehydrated Human Amniotic Membrane plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers.
The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The choice of compression will be at the discretion of the principle investigator.
The Screening Phase (1-14 days) consists of a series of screening assessments designed to determine eligibility followed by, for those who meet the eligibility criteria (described in more detail below), At or up to 14 days before the first Screening Period Visit (S1), written informed consent from the subject will be obtained by the Investigator or suitably qualified designee before the performance of any other protocol-specific procedure.
Subjects who have not been treated with compression therapy for the target ulcer must receive a minimum of 14 days of compression prior to enrollment.
At the first Screening Period Visit (S1), the Investigator will select the study (target) ulcer. Each subject will have only one VLU selected as the study (target) ulcer. In the situation where a subject has more than one VLU at the S1 visit, the Investigator will select the largest VLU that meets the eligibility criteria of the protocol as the study (target) ulcer.
The Screening Period is designed to determine whether subjects are eligible to proceed to the Treatment Period of the study.
The Treatment Phase (12 Weeks) begins with a series of assessments designed to confirm the subjects' continued eligibility. Subjects who continue to meet eligibility criteria will be randomized to one of three groups: (1) standard of care: multi-layer compression (2) weekly application of Amnioband Dehydrated Human Amniotic Membrane (3) biweekly applications of Amnioband Dehydrated Human Amniotic Membrane.
During the Treatment Phase, subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include Investigator assessment of ulcer healing and measurements of ulcer size using a digital camera device. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit.
Subjects in any of the three groups whose ulcers do not achieve closure at 12 weeks will be deemed treatment failures. Subjects in the control arm may cross over to the Amnioband arm if they fail to achieve closure although these subjects will not be included in the analysis.
- Conditions
- Venous Leg Ulcers
- Being tested
- Weekly application of Amnioband, Biweekly application of Amnioband, Standard of Care
- Keywords
- human amniotic membrane, compression therapy, venous leg ulcer
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly application of AmniobandOther
Weekly application of Amnioband.
Biweekly application of AmniobandOther
Biweekly application (every two weeks) of Amnioband.
Standard of CareOther
Standard of care for this study is weekly multi-layer compression bandaging.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Subjects randomized to this group will receive standard of care (multi-layer compression therapy). Receives: Other: Standard of Care |
| Weekly application of Amnioband | Experimental | Weekly application of Amnioband plus standard of care. Receives: Other: Weekly application of Amnioband; Other: Standard of Care |
| Biweekly application of Amnioband | Experimental | Biweekly application of Amnioband plus standard of care. Receives: Other: Biweekly application of Amnioband; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete ulcer closure
Ulcer closure is based on wound area measurement and absence of wound exudate.
Measured: 12 weeks
Secondary outcomes (5)
Proportion of ulcers achieving 40% ulcer closure
This is measured by wound area.
Measured: 4 weeks
Percentage of ulcers achieving complete closure
This is measured by wound area and absence of wound exudate.
Measured: 12 weeks
Incidence of adverse events
Measured: 12 weeks
Cost effectiveness
The per unit cost of providing wound care is known. The use of amniotic membrane to standard of care will be compared in terms of the cost of achieving healing.
Measured: 12 weeks
Reduction in pain between treatment groups
Pain is measured by subject report on a scale of 0 to 10.
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 posted20 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcersStudies 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SerenaGroup, Inc.
- Sponsor type
- Research network
- Collaborators
- Musculoskeletal Transplant Foundation
- Responsible party
- Principal investigator, Thomas Serena, SerenaGroup, Inc.
- Investigators
- Linda Squillante, Study director, Musculoskeletal Transplant Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609594
- Sponsor's protocol ID
- AMNIOVLU01
- Status last verified
- Sep 2018
- First submitted
- 16 Nov 2015
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. 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 Amnioband Dehydrated Human Amniotic Membrane and Standard of Care vs. Standard of Care Alone in the Treatment of Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT02609594
- Acronym / sponsor ID
- AMNIOVLU01
- Conditions
- Venous Leg Ulcers
- Keywords
- human amniotic membrane, compression therapy, venous leg ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- SerenaGroup, Inc.Research network
- Collaborators
- Musculoskeletal Transplant Foundation
- Study start
- Nov 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Nov 2015 (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.
Lower extremity ulcers pose significant clinical, humanistic and economic burdens on society. Millions of Americans are afflicted with painful, open, draining sores on their lower extremities. These sores are referred to as venous leg ulcerations (VLUs).1-5 Under the best of circumstances these ulcers require weeks or months to heal. Not uncommonly wound care specialists see patients who have suffered for years or faced amputation of the limb as their only option to alleviate the pain.
Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However, roughly half of patients suffering from venous ulcers will require advanced therapy. Human amniotic membrane replaces the damaged extracellular matrix characteristic of chronic ulcers. In addition, it contains cytokines that may accelerate healing. In clinical practice and recent studies, Dehydrated Human Amniotic Membrane has appeared to be as effective as bioengineered skin products. This RCT is designed to evaluate Amnioband Dehydrated Human Amniotic Membrane in venous leg ulcers.
Detailed description
This study is a multi-center, randomized, trial designed to evaluate the safety and effectiveness of Amnioband Dehydrated Human Amniotic Membrane plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers.
The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The choice of compression will be at the discretion of the principle investigator.
The Screening Phase (1-14 days) consists of a series of screening assessments designed to determine eligibility followed by, for those who meet the eligibility criteria (described in more detail below), At or up to 14 days before the first Screening Period Visit (S1), written informed consent from the subject will be obtained by the Investigator or suitably qualified designee before the performance of any other protocol-specific procedure.
Subjects who have not been treated with compression therapy for the target ulcer must receive a minimum of 14 days of compression prior to enrollment.
At the first Screening Period Visit (S1), the Investigator will select the study (target) ulcer. Each subject will have only one VLU selected as the study (target) ulcer. In the situation where a subject has more than one VLU at the S1 visit, the Investigator will select the largest VLU that meets the eligibility criteria of the protocol as the study (target) ulcer.
The Screening Period is designed to determine whether subjects are eligible to proceed to the Treatment Period of the study.
The Treatment Phase (12 Weeks) begins with a series of assessments designed to confirm the subjects' continued eligibility. Subjects who continue to meet eligibility criteria will be randomized to one of three groups: (1) standard of care: multi-layer compression (2) weekly application of Amnioband Dehydrated Human Amniotic Membrane (3) biweekly applications of Amnioband Dehydrated Human Amniotic Membrane.
During the Treatment Phase, subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include Investigator assessment of ulcer healing and measurements of ulcer size using a digital camera device. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit.
Subjects in any of the three groups whose ulcers do not achieve closure at 12 weeks will be deemed treatment failures. Subjects in the control arm may cross over to the Amnioband arm if they fail to achieve closure although these subjects will not be included in the analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareSubjects randomized to this group will receive standard of care (multi-layer compression therapy). |
| Weekly application of Amnioband | Experimental | Other: Weekly application of Amnioband, Other: Standard of CareWeekly application of Amnioband plus standard of care. |
| Biweekly application of Amnioband | Experimental | Other: Biweekly application of Amnioband, Other: Standard of CareBiweekly application of Amnioband plus standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- At least 18 years old.
- Ankle Brachial Pressure Index (ABI) > 0.75 OR SPP > 30 mmHg OR TCOM > 30 mmHg.*
- Presence of a venous leg ulcer extending through the full thickness of the skin but not down to muscle, tendon or bone.
- The largest ulcer will be designated the index ulcer and the only one included in the study. If other ulcerations are present on the same leg they have to be more than 2 cm apart from the index ulcer.
- Study ulcer (i.e. current episode of ulceration) has been present for greater than one month prior to the initial screening visit, and has failed to respond to documented conservative measures for greater than (1) one month duration and is excluded if it has undergone 12 months of continuous high strength compression therapy over its duration.
Key exclusion criteria (20 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.
- Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
- 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.
- Subjects with a history of more than two weeks treatment with immunosuppressants (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 |
|---|---|---|
| Weekly application of AmniobandWeekly application of Amnioband. | Other | Weekly application of Amnioband |
| Biweekly application of AmniobandBiweekly application (every two weeks) of Amnioband. | Other | Biweekly application of Amnioband |
| Standard of CareStandard of care for this study is weekly multi-layer compression bandaging. | Other | Biweekly application of Amnioband, Standard of Care, Weekly application of Amnioband |
Primary outcome
Time to complete ulcer closure
Time frame: 12 weeks
Ulcer closure is based on wound area measurement and absence of wound exudate.
5 secondary outcomes
Proportion of ulcers achieving 40% ulcer closure
Time frame: 4 weeks
Percentage of ulcers achieving complete closure
Time frame: 12 weeks
Incidence of adverse events
Time frame: 12 weeks
Cost effectiveness
Time frame: 12 weeks
Reduction in pain between treatment groups
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 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.
Heather Connell, CCRP contact
Linda Squillante study director
Musculoskeletal Transplant Foundation
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly application of Amnioband and Biweekly application of Amnioband in people with Venous Leg Ulcers, run by SerenaGroup, Inc. at 8 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 11 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather Connell, CCRP (617-383-3979), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete ulcer closure (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 7 Sep 2018.