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

NCT00648674 | Withdrawn Phase 4

• 1 other identifier: 07-MOA-001-AG
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Varicose Ulcer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Determine how venous leg ulcer (VLU) wounds transition from chronic to acute wound healing

  2 weeks

• Examine how Apligraf rescues deficiencies of chronic wounds (VLU) and promotes transition from chronic to acute wound

  2 weeks

• Determine growth factors induced by Apligraf in the wound

  2 weeks

• Determine growth factors suppressed by Apligraf in the wound

  2 weeks

• Safety endpoints assessed by monitoring adverse events

  5 months

Study Arms (1)

1

EXPERIMENTAL

Apligraf

Device: Apligraf

Interventions

Apligraf DEVICE

Applied at Day 0, possible re-application at Week 6

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organogenesis: lead

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Damien Bates, MD, PhD, FRACS (Plast.)

  Organogenesis Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: April 1, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 19, 2015

Record last verified: 2015-08