Comparison of Human Allograft to Apligraf for Venous Leg Ulcers
Public ClinicalTrials.gov record NCT02047084. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Prospective Controlled Head-to-head Clinical Trial Comparing a Bioengineered Skin Substitute to a Biologically Active Human Skin Allograft for the Treatment of Venous Leg Ulcers.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Given the propensity for venous leg ulcers to become refractory, long standing lesions, incorporating active biologic grafts into the standard compression therapy, has shown to accelerate wound healing. The two products to be compared in this study are both commonly used for the treatment of venous leg ulcers. Apligraf is considered a medical device by the FDA, and was cleared for the treatment of venous leg ulcers in 1998. It is a staple for the treatment of venous leg ulcers, and is widely used throughout the United States. It is composed of a type 1 collagen matrix in which human foreskin-derived neonatal fibroblasts are grown, and over which human foreskin-derived neonatal keratinocytes are then cultured and allowed to stratify. TheraSkin is composed of a split thickness skin graft harvested within 24 hours post-mortem, from an organ donor who has cleared the standard safety screenings. It is classified by the FDA as a donated tissue. Once harvested, the graft is sanitized according to FDA specifications, and cryopreserved, until it is delivered to the clinic for application to the foot ulcer. It is also a widely used treatment for diabetic foot ulcers. TREATMENT RATIONALE FOR THIS STUDY Chronic wounds of the lower extremities affect a substantial proportion of the population. Venous leg ulcers (VLU) account for 40-70% of lower extremity wounds. The standard of care for treatment of VLU's in wound centers in the United States is compression therapy combined with application of biologic graft materials to the wound bed. This study may assist physicians who treat VLU's by comparing efficacy and costs of two commonly used biologic graft materials for VLU's in a randomized prospective study. In addition to standard compression therapy, this investigation will be a head-to-head study comparing widely used bio-engineered skin substitute (Apligraf) to cryopreserved, human skin allograft (Theraskin). There is no randomized, prospective data comparing these two graft options in the treatment of VLU's.
Study identification
- NCT ID
- NCT02047084
- Recruitment status
- Enrolling by invitation
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 21 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2013
- Primary completion
- Dec 30, 2025
- Completion
- Dec 30, 2026
- Last update posted
- Nov 28, 2023
2013 – 2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Francis Wound Healing Center | Greenville | South Carolina | 29615 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02047084, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 28, 2023 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02047084 live on ClinicalTrials.gov.