Varicose UlcerPhase 4NCT00648674
A Post-Marketing Clinical Study of Apligraf for Venous Leg Ulcers
A Phase 4 study testing Apligraf in people with Varicose Ulcer, run by Organogenesis.
Trial summary
Single site clinical study utilizing the novel technology of microarrays to identify and characterize the molecular mechanisms through which Apligraf promotes healing of venous leg ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Varicose Ulcer
- What is being tested?
- Apligraf
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Mar 2010
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has non-infected partial or full-thickness venous leg ulcer for a duration of four weeks or greater which has not adequately responded to conventional therapy
- Stage II or III ulcer as defined by the IAET/WOCN ulcer classification guide listed in Appendix IV.
- Subject is female and 18 years of age or older.
- Subject with venous leg ulcer (target ulcer) between 5 - 40 cm2 in size.
- Sexually active females must be practicing a medically proven form of contraception during the course of the study period.
- Subject or legal guardian must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form.
- Subject and/or legal guardian must be able and willing to follow study procedures and instructions.
Who cannot join
- Subject whose target ulcer has healed 60% or greater in area from post debridement (if applicable) Baseline Screen (Visit 1) to post debridement Day 0 (Visit 2) as determined by wound tracings.
- Subjects who are being treated with VAC® (Vacuum Assisted Closure™) Therapy.
- Subject has arterial disease as determined by an Ankle Brachial Index (ABI ) of <0.65.
- Subject with any systemic condition like uncontrolled diabetes mellitus (glycosylated HbA1C > 12%), cancer (biopsy confirmed active malignancy), positive HIV test, or any disorder(s) that may compromise wound healing.
- Subjects who are currently receiving, or have received at any time within one month prior to entry into the study, corticosteroids (>15 mg/day), immunosuppressive agents, radiation therapy, hemodialysis or chemotherapy. Anticipated use of the above agents will exclude subjects from entry into the study.
- Clinical vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases.
Show all 17Show fewer
- Signs and symptoms of cellulitis or osteomyelitis.
- Necrotic or avascular ulcer beds.
- Venous leg ulcer with exposed bone, tendon or fascia.
- Subject with the presence of recent infections in the area intended for treatment.
- Known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium.
- Subject who is lactating or pregnant (hCG positive as determined by lab testing).
- Subject with liver (ALT/SGPT, ALP, AST/SGOT, bilirubin, Albumin, total protein, LDH) and/or renal function (BUN and creatinine) tests greater than 2 x upper limit of normal (ULN) or Albumin < 2.5 mg/dL.
- Subject enrolled in any wound or investigational device study for any disease within the past four weeks.
- Subject previously treated at target site with Apligraf, Dermagraft or any other cell therapy at the target site.
- Subject with a history of alcohol or substance abuse within the previous year, which could interfere with study compliance such as inability to attend scheduled study visits or compliance with home dressing changes.
- 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
About this study
Official title: A Prospective, Single-Site Study to Identify and Characterize the Molecular Mechanisms of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers
Single site clinical study utilizing the novel technology of microarrays to identify and characterize the molecular mechanisms through which Apligraf promotes healing of venous leg ulcers.
- Conditions
- Varicose Ulcer
- Being tested
- Apligraf
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApligrafDevice
Applied at Day 0, possible re-application at Week 6
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Apligraf Receives: Device: Apligraf |
What is being measured
The primary outcome is the main question the study is designed to answer.
To use the novel technology of microarrays to identify and characterize the molecular mechanisms through which Apligraf promotes healing of venous leg ulcers.
Measured: 2 weeks
Secondary outcomes (5)
Determine how venous leg ulcer (VLU) wounds transition from chronic to acute wound healing
Measured: 2 weeks
Examine how Apligraf rescues deficiencies of chronic wounds (VLU) and promotes transition from chronic to acute wound
Measured: 2 weeks
Determine growth factors induced by Apligraf in the wound
Measured: 2 weeks
Determine growth factors suppressed by Apligraf in the wound
Measured: 2 weeks
Safety endpoints assessed by monitoring adverse events
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Damien Bates, MD, PhD, FRACS (Plast.), Study director, Organogenesis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648674
- Sponsor's protocol ID
- 07-MOA-001-AG
- Status last verified
- Aug 2015
- First submitted
- 28 Mar 2008
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Site Study to Identify and Characterize the Molecular Mechanisms of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT00648674
- Acronym / sponsor ID
- 07-MOA-001-AG
- Conditions
- Varicose Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 1 Apr 2008 (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.
Single site clinical study utilizing the novel technology of microarrays to identify and characterize the molecular mechanisms through which Apligraf promotes healing of venous leg ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: ApligrafApligraf |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has non-infected partial or full-thickness venous leg ulcer for a duration of four weeks or greater which has not adequately responded to conventional therapy
- Stage II or III ulcer as defined by the IAET/WOCN ulcer classification guide listed in Appendix IV.
- Subject is female and 18 years of age or older.
- Subject with venous leg ulcer (target ulcer) between 5 - 40 cm2 in size.
- Sexually active females must be practicing a medically proven form of contraception during the course of the study period.
Key exclusion criteria (17 listed)
- Subject whose target ulcer has healed 60% or greater in area from post debridement (if applicable) Baseline Screen (Visit 1) to post debridement Day 0 (Visit 2) as determined by wound tracings.
- Subjects who are being treated with VAC® (Vacuum Assisted Closure™) Therapy.
- Subject has arterial disease as determined by an Ankle Brachial Index (ABI ) of <0.65.
- Subject with any systemic condition like uncontrolled diabetes mellitus (glycosylated HbA1C > 12%), cancer (biopsy confirmed active malignancy), positive HIV test, or any disorder(s) that may compromise wound healing.
- Subjects who are currently receiving, or have received at any time within one month prior to entry into the study, corticosteroids (>15 mg/day), immunosuppressive agents, radiation therapy, hemodialysis or chemotherapy. Anticipated use of the above agents will exclude subjects from entry into 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 |
|---|---|---|
| ApligrafApplied at Day 0, possible re-application at Week 6 | Device | 1 |
Primary outcome
To use the novel technology of microarrays to identify and characterize the molecular mechanisms through which Apligraf promotes healing of venous leg ulcers.
Time frame: 2 weeks
5 secondary outcomes
Determine how venous leg ulcer (VLU) wounds transition from chronic to acute wound healing
Time frame: 2 weeks
Examine how Apligraf rescues deficiencies of chronic wounds (VLU) and promotes transition from chronic to acute wound
Time frame: 2 weeks
Determine growth factors induced by Apligraf in the wound
Time frame: 2 weeks
Determine growth factors suppressed by Apligraf in the wound
Time frame: 2 weeks
Safety endpoints assessed by monitoring adverse events
Time frame: 5 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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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.
Damien Bates, MD, PhD, FRACS (Plast.) study director
Organogenesis Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apligraf in people with Varicose Ulcer, run by Organogenesis.
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 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: withdrawn, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To use the novel technology of microarrays to identify and characterize the molecular mechanisms through which Apligraf promotes healing of venous leg ulcers. (time frame: 2 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 19 Aug 2015.