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

Completed · Phase 4

Conditions studied: Venous Ulcer

In brief

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.

Key facts

Study ID

NCT01327937

Run by

Organogenesis

People needed

30

Starts

2011-03-01

Expected to finish

2013-12-01

Last updated by the study team

2015-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Subjects who require VAC® (Vacuum Assisted Closure™) therapy on or after Day 0 Study visit.
• Subject has arterial disease as determined by an Ankle Brachial Index (ABI) measurement of <0.65.
• Subject with any systemic or congenital condition like uncontrolled diabetes mellitus, positive HIV test, or any disorder(s) that may compromise wound healing.
• 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.)
• 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.)
• Clinical vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases.
• Signs and symptoms of cellulitis or osteomyelitis at the target ulcer.
• Avascular target ulcer beds. (Ulcers of mixed etiology such as arterial disease with VLU will be excluded.)
• Target ulcer with exposed bone, tendon or fascia.
• Known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium.
• Subject enrolled in any wound or investigational study (drug, biologic or device) for any disease within 30 days of the Screening visit.
• Subject previously treated with Apligraf, Dermagraft® or any other cell therapy at the target ulcer site within 30 days of the Screening visit.
• 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.
• 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.
• 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.
• Target ulcer has not decreased in size by > 40% from Screening to Day 0.
• Confirmed gene expression overlap between the subject's cells (buccal swab) and the cells contained in Apligraf.

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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