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

Venous Ulcer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

Subjects with a ≥5 cm2, non-infected target ulcer that has not reduced in area by ≥ 40% since the Screening visit will be randomized at Day 0 to either Apligraf or Control. After enrollment of 25 subjects, randomization will be discontinued and all remaining subjects will receive Apligraf.

Once the target ulcer is assessed by the Investigator as healed at a study visit, the subject's participation in the study is completed (eg, assessed as healed at Week 3, subject would not be required to complete any subsequent study visits).

Apligraf Group (Day 0 to Week 4) Prior to all applications, Apligraf will be fenestrated (perforated) in a standardized manner using a #11 blade with 6 fenestrations per 44 cm2.

For those subjects randomized to the Apligraf group, after Apligraf application, the dressing regimen will include a foam dressing (eg. Mepilex) and a 4 layered compression bandage system (eg. Profore) which will be changed weekly by the Investigator.

After the initial Apligraf application at study Day 0, Apligraf may be applied weekly thereafter for an additional 4 weeks at study Weeks 1, 2, 3, and 4, if, upon visual inspection, adherent Apligraf wound coverage is < 100%.

At Week 4, the area of the target ulcer will be compared to the area of the target ulcer at Day 0 to determine if the target ulcer is PTH or NPTH.

Apligraf subjects that do not achieve CWC by Week 5 will enter the Follow-Up Phase at that time.

Control Group (Day 0 to Week 4 [PTH] or Day 0 to Week 8 [NPTH] Beginning at Day 0, subjects randomized to the Control group will receive the standard dressing regimen which includes a foam dressing (e.g. Mepilex®) and a four layered compression bandage system (e.g. Profore™) which will be changed weekly by the Investigator.

At study Week 4, the size of the ulcer will be compared to the size at study Day 0 to determine if the ulcer is demonstrating "Predicted to Heal" (PTH), defined as >40% reduction in ulcer surface area compared with study Day 0, or "Not Predicted to Heal (NPTH), defined as <40% reduction in ulcer surface area compared with study Day 0.

Control PTH subjects that do not achieve CWC by Week 4 will continue to receive Control treatment and will enter the Follow-Up Phase at Week 5.

Control NPTH subjects will receive Apligraf beginning at Week 4. Prior to all applications, Apligraf will be fenestrated (perforated) in a standardized manner using a #11 blade with 6 fenestrations per 44 cm2. After the initial Apligraf application at Week 4, Apligraf may be applied weekly thereafter for an additional 4 weeks at study Weeks 5, 6, 7, and 8 if upon visual inspection, adherent Apligraf wound coverage is < 100%. After Apligraf application, the standard dressing regimen will be applied over the target ulcer. The dressing will be changed weekly by the Investigator. At Week 8, the area of the target ulcer will be compared to the area of the target ulcer at Week 4 to determine if the target ulcer is PTH or NPTH.

Control NPTH subjects that do not achieve CWC by Week 9 will enter the Follow-up Phase at that time. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• Venous Ulcer

• NCT number: NCT01327937
• Study type: Interventional
• Source: Organogenesis
• Status: Completed
• Phase: Phase 4
• Start date: March 2011
• Completion date: December 2013