Venous Leg UlcersPhase 4NCT02011724
A Study Of Pain And Quality Of Life Outcomes In Subjects With a Single Painful Venous Leg Ulcer Treated With Apligraf®
A Phase 4 study testing Apligraf in people with Venous Leg Ulcers, run by Organogenesis at 1 site in United States.
Trial summary
The objective of the study is to demonstrate that treatment with Apligraf reduces venous leg ulcer (VLU)-related pain and improves the quality of life (QOL) of patients with a painful VLU. 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?
- Apligraf
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jan 2014
- Phase
- Phase 4
- 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
- Subject is a minimum of 18 years of age.
- Subject has read, understood, and signed an Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
- Subject is able and willing to follow study procedures and instructions.
- Subject reports moderate VLU-related pain (defined as ≥4 based on maximum pain level over preceding 24 hours) on numeric rating scale (NRS) at both Week -2 and Day 0).
- Subject has a partial or full-thickness VLU between 1-60 cm2 and 1-36 months duration, which, in the opinion of the Investigator, has not adequately responded to conventional ulcer therapy.
- Female subject of childbearing potential has a documented negative urine pregnancy test.
- Subject (male or female) agrees to use highly effective methods of contraception for the duration of the study.
Who cannot join
- Subject has more than 1 VLU.
- Female subject who is lactating.
- Subject with significant or severe non VLU-related chronic pain which, in the Investigator's opinion, would impact subject's ability to evaluate their VLU-related pain. Subject with non-VLU-related chronic pain must be on a stable pain medication regimen and must, in the Investigator's opinion, not be anticipated to require a new pain medication for the chronic pain condition during the course of the study.
- Subject is not willing to discontinue the use of topical analgesics at the VLU (topical anesthetic is permitted for debridement).
- Subject who has arterial disease, as determined by an ankle-brachial index (ABI), of <0.65.
- Subject who has received an investigational drug, device, or biological/bioactive treatment within 30 days prior to study enrollment.
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- Subject who is scheduled to have a vascular intervention on the study extremity during the study.
- Subject with a biopsy confirmed active malignancy at the VLU. Also, subject with any active malignancy not at the VLU, with the exception of squamous cell carcinoma or basal cell carcinoma.
- Subject who is currently receiving, anticipates receiving, or has received, at any time within 30 days prior to Screening visit, topical corticosteroids at the VLU.
- Subject has vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases.
- Subject has signs and symptoms of wound infection, cellulitis, or osteomyelitis at the VLU.
- Subject has a VLU with an avascular wound bed.
- Subject has a VLU with exposed bone, tendon, or fascia.
- Subject has other wounds (DFU, surgical, etc.) on the same limb as the VLU.
- Subject has a known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium.
- Subject previously treated with Apligraf, or any other cell or tissue-based product at the VLU within 30 days of the Screening visit.
- Subject who, in the opinion of the Investigator, has a history of alcohol or substance abuse within the previous year that could interfere with study compliance (eg, inability to attend scheduled study visits).
- Subject, who in the opinion of the Investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: An Open Label, Multi Center, Post Marketing Study Of Pain And Quality Of Life Outcomes In Subjects With a Single Painful Venous Leg Ulcer Treated With Apligraf®
The objective of the study is to demonstrate that treatment with Apligraf reduces venous leg ulcer (VLU)-related pain and improves the quality of life (QOL) of patients with a painful VLU.
- Conditions
- Venous Leg Ulcers
- Being tested
- Apligraf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApligrafDevice
| Study group | Role | What they receive |
|---|---|---|
| Apligraf | Experimental | Not described Receives: Device: Apligraf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in maximum VLU-related pain at Week 5
Based on the maximum pain levels during the preceding 24 hours
Measured: Day 0 - Week 5
Secondary outcomes (4)
Reduction in maximum VLU-related pain at 48 hours following initial Apligraf application
Measured: Day 0 - 48 hours after Apligraf application
Reduction on SF-12v2 - Pain Enhanced Health Survey at Week 5
Measured: Day 0 - Week 5
Reduction in class and/or dose of VLU-related pain medications at Week 5
Measured: Day 0 - Week 5
Reduction on Cardiff Wound Impact Schedule (CWIS) at Week 5
Measured: Day 0 - Week 5
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 startNov 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (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 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William A. Marston, MD, Principal investigator, Division of Vascular Surgery, UNC at Chapel HillScott Gorenstein, MD, Principal investigator, Winthrop University HospitalDavid G. Armstrong, DPM, MD, PhD, Principal investigator, Department of Surgery, University of Arizona College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011724
- Sponsor's protocol ID
- 13-VLU-003-AG
- Status last verified
- Dec 2013
- First submitted
- 10 Dec 2013
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi Center, Post Marketing Study Of Pain And Quality Of Life Outcomes In Subjects With a Single Painful Venous Leg Ulcer Treated With Apligraf®
- ClinicalTrials.gov ID
- NCT02011724
- Acronym / sponsor ID
- 13-VLU-003-AG
- Conditions
- Venous Leg Ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- 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 objective of the study is to demonstrate that treatment with Apligraf reduces venous leg ulcer (VLU)-related pain and improves the quality of life (QOL) of patients with a painful VLU.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apligraf | Experimental | Device: Apligraf |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is a minimum of 18 years of age.
- Subject has read, understood, and signed an Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
- Subject is able and willing to follow study procedures and instructions.
- Subject reports moderate VLU-related pain (defined as ≥4 based on maximum pain level over preceding 24 hours) on numeric rating scale (NRS) at both Week -2 and Day 0).
- Subject has a partial or full-thickness VLU between 1-60 cm2 and 1-36 months duration, which, in the opinion of the Investigator, has not adequately responded to conventional ulcer therapy.
Key exclusion criteria (18 listed)
- Subject has more than 1 VLU.
- Female subject who is lactating.
- Subject with significant or severe non VLU-related chronic pain which, in the Investigator's opinion, would impact subject's ability to evaluate their VLU-related pain. Subject with non-VLU-related chronic pain must be on a stable pain medication regimen and must, in the Investigator's opinion, not be anticipated to require a new pain medication for the chronic pain condition during the course of the study.
- Subject is not willing to discontinue the use of topical analgesics at the VLU (topical anesthetic is permitted for debridement).
- Subject who has arterial disease, as determined by an ankle-brachial index (ABI), of <0.65.
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 |
|---|---|---|
| Apligraf | Device | Apligraf |
Primary outcome
Percent reduction in maximum VLU-related pain at Week 5
Time frame: Day 0 - Week 5
Based on the maximum pain levels during the preceding 24 hours
4 secondary outcomes
Reduction in maximum VLU-related pain at 48 hours following initial Apligraf application
Time frame: Day 0 - 48 hours after Apligraf application
Reduction on SF-12v2 - Pain Enhanced Health Survey at Week 5
Time frame: Day 0 - Week 5
Reduction in class and/or dose of VLU-related pain medications at Week 5
Time frame: Day 0 - Week 5
Reduction on Cardiff Wound Impact Schedule (CWIS) at Week 5
Time frame: Day 0 - Week 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
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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.
William A. Marston, MD principal investigator
Division of Vascular Surgery, UNC at Chapel Hill
Scott Gorenstein, MD principal investigator
Winthrop University Hospital
David G. Armstrong, DPM, MD, PhD principal investigator
Department of Surgery, University of Arizona College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apligraf in people with Venous Leg Ulcers, run by Organogenesis 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 7 inclusion and 18 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 13 Dec 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Percent reduction in maximum VLU-related pain at Week 5 (time frame: Day 0 - Week 5). 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 13 Dec 2013.