- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00648674
A Post-Marketing Clinical Study of Apligraf for Venous Leg Ulcers
August 18, 2015 updated by: Organogenesis
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.
Study Overview
Study Type
Interventional
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Apligraf
|
Applied at Day 0, possible re-application at Week 6
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine how venous leg ulcer (VLU) wounds transition from chronic to acute wound healing
Time Frame: 2 weeks
|
2 weeks
|
Examine how Apligraf rescues deficiencies of chronic wounds (VLU) and promotes transition from chronic to acute wound
Time Frame: 2 weeks
|
2 weeks
|
Determine growth factors induced by Apligraf in the wound
Time Frame: 2 weeks
|
2 weeks
|
Determine growth factors suppressed by Apligraf in the wound
Time Frame: 2 weeks
|
2 weeks
|
Safety endpoints assessed by monitoring adverse events
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Damien Bates, MD, PhD, FRACS (Plast.), Organogenesis Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Anticipated)
March 1, 2010
Study Completion (Anticipated)
March 1, 2010
Study Registration Dates
First Submitted
March 28, 2008
First Submitted That Met QC Criteria
March 28, 2008
First Posted (Estimate)
April 1, 2008
Study Record Updates
Last Update Posted (Estimate)
August 19, 2015
Last Update Submitted That Met QC Criteria
August 18, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-MOA-001-AG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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