A Post-Marketing Clinical Study of Apligraf for Venous Leg Ulcers

Varicose Ulcer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00648674
• Other study ID #: 07-MOA-001-AG
• Status: Withdrawn
• Phase: Phase 4
• First received: March 28, 2008
• Last updated: August 18, 2015
• Start date: July 2008
• Est. completion date: March 2010

Study information

• Verified date: August 2015
• Source: Organogenesis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer

Intervention

Device:
• Apligraf
Applied at Day 0, possible re-application at Week 6

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organogenesis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To use the novel technology of microarrays to identify and characterize the molecular mechanisms through which Apligraf promotes healing of venous leg ulcers.		2 weeks	No
Secondary	Determine how venous leg ulcer (VLU) wounds transition from chronic to acute wound healing		2 weeks	No
Secondary	Examine how Apligraf rescues deficiencies of chronic wounds (VLU) and promotes transition from chronic to acute wound		2 weeks	No
Secondary	Determine growth factors induced by Apligraf in the wound		2 weeks	No
Secondary	Determine growth factors suppressed by Apligraf in the wound		2 weeks	No
Secondary	Safety endpoints assessed by monitoring adverse events		5 months	Yes