Venous Leg Ulcers
Conditions
Brief summary
The objective of the study is to demonstrate that treatment with Apligraf reduces venous leg ulcer (VLU)-related pain and improves the quality of life (QOL) of patients with a painful VLU.
Interventions
DEVICEApligraf
Sponsors
Organogenesis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is a minimum of 18 years of age. * Subject has read, understood, and signed an Institutional Review Board (IRB)-approved Informed Consent Form (ICF). * Subject is able and willing to follow study procedures and instructions. * Subject reports moderate VLU-related pain (defined as ≥4 based on maximum pain level over preceding 24 hours) on numeric rating scale (NRS) at both Week -2 and Day 0). * Subject has a partial or full-thickness VLU between 1-60 cm2 and 1-36 months duration, which, in the opinion of the Investigator, has not adequately responded to conventional ulcer therapy. * Female subject of childbearing potential has a documented negative urine pregnancy test. * Subject (male or female) agrees to use highly effective methods of contraception for the duration of the study.
Exclusion criteria
* Subject has more than 1 VLU. * Female subject who is lactating. * Subject with significant or severe non VLU-related chronic pain which, in the Investigator's opinion, would impact subject's ability to evaluate their VLU-related pain. Subject with non-VLU-related chronic pain must be on a stable pain medication regimen and must, in the Investigator's opinion, not be anticipated to require a new pain medication for the chronic pain condition during the course of the study. * Subject is not willing to discontinue the use of topical analgesics at the VLU (topical anesthetic is permitted for debridement). * Subject who has arterial disease, as determined by an ankle-brachial index (ABI), of \<0.65. * Subject who has received an investigational drug, device, or biological/bioactive treatment within 30 days prior to study enrollment. * Subject who is scheduled to have a vascular intervention on the study extremity during the study. * Subject with a biopsy confirmed active malignancy at the VLU. Also, subject with any active malignancy not at the VLU, with the exception of squamous cell carcinoma or basal cell carcinoma. * Subject who is currently receiving, anticipates receiving, or has received, at any time within 30 days prior to Screening visit, topical corticosteroids at the VLU. * Subject has vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases. * Subject has signs and symptoms of wound infection, cellulitis, or osteomyelitis at the VLU. * Subject has a VLU with an avascular wound bed. * Subject has a VLU with exposed bone, tendon, or fascia. * Subject has other wounds (DFU, surgical, etc.) on the same limb as the VLU. * Subject has a known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium. * Subject previously treated with Apligraf, or any other cell or tissue-based product at the VLU within 30 days of the Screening visit. * Subject who, in the opinion of the Investigator, has a history of alcohol or substance abuse within the previous year that could interfere with study compliance (eg, inability to attend scheduled study visits). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent reduction in maximum VLU-related pain at Week 5 | Day 0 - Week 5 | Based on the maximum pain levels during the preceding 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in maximum VLU-related pain at 48 hours following initial Apligraf application | Day 0 - 48 hours after Apligraf application |
| Reduction in class and/or dose of VLU-related pain medications at Week 5 | Day 0 - Week 5 |
| Reduction on Cardiff Wound Impact Schedule (CWIS) at Week 5 | Day 0 - Week 5 |
| Reduction on SF-12v2 - Pain Enhanced Health Survey at Week 5 | Day 0 - Week 5 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reduction in VLU-related pain using both maximum and average pain | Day 0 - Weeks 1, 2, 3, and 4 | From baseline (Day 0) to Weeks 1, 2, 3 and 4 |
| Reduction in average VLU-related pain at Week 5. | Day 0 - Week 5 | — |
Countries
United States
Outcome results
None listed