A Post Marketing Study of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Organogenesis
ClinicalTrials.gov Identifier:
NCT01327937
First received: March 31, 2011
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

The overall study objective is to use microarray technology to identify and characterize the gene expression of multiple relevant genes in biopsies of non-healing venous ulcers.


Condition Intervention Phase
Venous Ulcer
Device: Apligraf
Other: Standard of care dressings
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Single-Site Post Marketing Study to Identify & Characterize the Molecular Mechanisms of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers

Resource links provided by NLM:


Further study details as provided by Organogenesis:

Primary Outcome Measures:
  • Determine changes in gene expression in subjects receiving Apligraf (includes Apligraf & Control NPTH) compared to 1 week post treatment [ Time Frame: Apligraf group - Day 0 & Week 1; Control NPTH group-Weeks 4 & 5 ] [ Designated as safety issue: No ]
    Not Predicted to Heal (NPTH) defined as <40% reduction in ulcer surface area from Day 0 to Week 4


Secondary Outcome Measures:
  • Determine changes in gene expression in subjects receiving Apligraf (includes Apligraf & Control NPTH)compared to subjects not receiving Apligraf at time of initial treatment and at 1 week post treatment [ Time Frame: Apligraf group-Day 0 & Week 1; Control NPTH group-Weeks 4 & 5 ] [ Designated as safety issue: No ]
    NPTH defined as above

  • Determine differences in gene expression in following groups (see description section) [ Time Frame: Apligraf group-Day 0 & Week 1; Control NPTH group-Weeks 4 & 5 ] [ Designated as safety issue: No ]
    1. Apligraf (APG) subjects Predicted to Heal (PTH) compared to Apligraf subjects Not Predicted to Heal (NPTH)
    2. APG subjects PTH compared to Control subjects PTH
    3. APG subjects NPTH compared to Control subjects NPTH
    4. Control subjects PTH compared to Control subjects NPTH
    5. All subjects (Apligraf and Control) PTH compared to all subjects NPTH

    Also evaluate validity of surrogate endpoint (ulcer decrease of>/= 40% from Day 0 to Week 4) for complete wound closure (CWC*) by Week 24

    * CWC defined as 100% epithelialization with absence of drainage



Enrollment: 30
Study Start Date: March 2011
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Apligraf Group Device: Apligraf
Apligraf group - Applied at Day 0, Weeks 1-4 (maximum of 5 applications) Also cross-over at Week 4 for Control NPTH group - Apligraf applied at Week 4, Weeks 5-8 (maximum of 5 applications)
Placebo Comparator: Control Group Other: Standard of care dressings
Standard dressing regimen - Foam dressing (eg, Mepilex) and 4 layered compression system (eg, Profore)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has at least 1 clinically non-infected full-thickness venous leg ulcer (VLU) at least 5 cm2 in size.
  2. Subject is at least 18 years of age or older.
  3. Subject must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form.
  4. Subject must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

  1. Subjects who require VAC® (Vacuum Assisted Closure™) therapy on or after Day 0 Study visit.
  2. Subject has arterial disease as determined by an Ankle Brachial Index (ABI) measurement of <0.65.
  3. Subject with any systemic or congenital condition like uncontrolled diabetes mellitus, positive HIV test, or any disorder(s) that may compromise wound healing.
  4. Subjects with carcinomas located at the target ulcer with biopsy confirmed active malignancy. (Subjects with other carcinoma locations would not be excluded from entry into the study.)
  5. Subjects who are currently receiving, or have received at any time within 30 days prior to Screening visit, non-inhaled corticosteroids except topical steroids not at the target ulcer (Inhaled steroid therapy is acceptable on study.), immunosuppressive agents, radiation therapy, hemodialysis, peritoneal dialysis or chemotherapy. (Anticipated use of the above agents or therapies would exclude subject from entry into the study.)
  6. Clinical vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases.
  7. Signs and symptoms of cellulitis or osteomyelitis at the target ulcer.
  8. Avascular target ulcer beds. (Ulcers of mixed etiology such as arterial disease with VLU will be excluded.)
  9. Target ulcer with exposed bone, tendon or fascia.
  10. Known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium.
  11. Subject enrolled in any wound or investigational study (drug, biologic or device) for any disease within 30 days of the Screening visit.
  12. Subject previously treated with Apligraf, Dermagraft® or any other cell therapy at the target ulcer site within 30 days of the Screening visit.
  13. 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.
  14. Subject who is a current smoker or has not ceased smoking 6 months prior to the Screening visit, or in the opinion of the Investigator, has a smoking history that may compromise wound healing.
  15. 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.
  16. Target ulcer has not decreased in size by > 40% from Screening to Day 0.
  17. Confirmed gene expression overlap between the subject's cells (buccal swab) and the cells contained in Apligraf.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327937

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
Organogenesis
Investigators
Principal Investigator: Evangelos Badiavas, MD, PhD University of Miami
  More Information

No publications provided

Responsible Party: Organogenesis
ClinicalTrials.gov Identifier: NCT01327937     History of Changes
Other Study ID Numbers: 09-MOA-002-AG
Study First Received: March 31, 2011
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014