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

NCT01327937 | Completed Phase 4

• 1 other identifier: 09-MOA-002-AG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Ulcer

Outcome Measures

Primary Outcomes (1)

• Determine changes in gene expression in subjects receiving Apligraf (includes Apligraf & Control NPTH) compared to 1 week post treatment

  Not Predicted to Heal (NPTH) defined as \<40% reduction in ulcer surface area from Day 0 to Week 4

  Apligraf group - Day 0 & Week 1; Control NPTH group-Weeks 4 & 5

Secondary Outcomes (2)

• 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

  Apligraf group-Day 0 & Week 1; Control NPTH group-Weeks 4 & 5

• Determine differences in gene expression in following groups (see description section)

  Apligraf group-Day 0 & Week 1; Control NPTH group-Weeks 4 & 5

Study Arms (2)

Apligraf Group

ACTIVE COMPARATOR

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)

Device: Apligraf

Standard of Care Dressing Group

PLACEBO COMPARATOR

Standard of care dressing regimen - Foam dressing (eg, Mepilex) and 4 layered compression system (eg, Profore)

Other: Standard of Care Dressing Group

Interventions

Apligraf DEVICE

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)

Apligraf Group

Standard of Care Dressing Group OTHER

Standard dressing regimen - Foam dressing (eg, Mepilex) and 4 layered compression system (eg, Profore)

Standard of Care Dressing Group

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Organogenesis: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (2)

• Stone RC, Stojadinovic O, Sawaya AP, Glinos GD, Lindley LE, Pastar I, Badiavas E, Tomic-Canic M. A bioengineered living cell construct activates metallothionein/zinc/MMP8 and inhibits TGFbeta to stimulate remodeling of fibrotic venous leg ulcers. Wound Repair Regen. 2020 Mar;28(2):164-176. doi: 10.1111/wrr.12778. Epub 2019 Dec 4.

  PMID: 31674093 DERIVED

• Stone RC, Stojadinovic O, Rosa AM, Ramirez HA, Badiavas E, Blumenberg M, Tomic-Canic M. A bioengineered living cell construct activates an acute wound healing response in venous leg ulcers. Sci Transl Med. 2017 Jan 4;9(371):eaaf8611. doi: 10.1126/scitranslmed.aaf8611.

  PMID: 28053158 DERIVED

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

• Evangelos Badiavas, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2011
• First Posted: April 4, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

US (1)