Comparison of Human Allograft to Apligraf for Venous Leg Ulcers

Launched by SOLSYS MEDICAL LLC · Jan 25, 2014

Keywords

ClinConnect Summary

The products to be considered will be Apligraf, which is a bioengineered skin substitute, and TheraSkin, which is a cryopreserved split-thickness human skin allograft. This is a head-to-head designed study to observe the performance of each product and compare the results so that the clinician can readily see advantages in healing times, infection rates, and costs associated with each product. The study sponsors are Soluble Systems and Life Net Health.

The Study will have three phases:

The first phase will consist of a series of screening assessments designed to determine eligibility. The...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria:Inclusion Criteria: Subjects are required to meet all of the following inclusion criteria for study enrollment and subsequent randomization.
• • 1. A signed and dated informed consent form has been obtained from the subject.
• • 2. Subject is 18yrs or older and able and willing to comply with study procedures.
• • 3. Ulcer size (area) is \>2cm2 but \<40cm2 (post-debridement at time of randomization) and not deeper than 5mm.
• • 4. Study ulcer duration is \>30days despite conventional wound care at the time of screening visit.
• • Note: If the subject has more than one qualifying VLU, the ulcer designated as the study ulcer will be at the discretion of the Investigator.
• • 5. Subject has adequate arterial perfusion with an ankle brachial index \>0.5 or biphasic or triphasic Doppler signals in the dorsalis pedis and posterior tibial arteries of the affected extremity.
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• • Exclusion Criteria:Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.
• • 1. Subject has suspected gangrene or wound infection on any part of the affected limb. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after eradication of the infection).
• • 2. Subject has a history of hypersensitivity to bovine collage and agarose shipping media as listed in the Apligraf directions for use.
• • 3. Subject has a history of hypersensitivity to any of the antibiotics or preservation agents listed in the TheraSkin Instructions for Use.
• • 4. Subject was previously treated under this clinical study protocol.
• • 5. Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug/treatment within 30 days of randomization visit.
• • 6. Subject is currently receiving (i.e., within 30 days of randomization visit) or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with or affect the rate and quality of wound healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy within the 12 months prior to randomization, dialysis, radiation therapy to the foot, vascular surgery, angioplasty or thrombolysis).
• • 7. Subject has ulcers secondary to a disease other than venous ulcers, e.g., vasculitis, neoplasm's, or hematological disorders.
• • 8. Subject has osteomyelitis with necrotic soft bone. (If the Investigator suspects the presence of osteomyelitis, the diagnosis must be confirmed by plain film X-ray.)
• • 9. Subject has a history of bone cancer or metastatic disease on the affected limb, radiation therapy to the foot or has had chemotherapy within the 12 months prior to randomization.
• • 10. Subject has been treated with wound dressings that include growth factors, engineered tissues, or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®, TheraSkin®, GraftJacket®, OASIS®, Primatrix®, Matristem®, etc.) within 30 days of randomization.
• 11. Subject has a history of or any of the following current illnesses or conditions (other than diabetes) that would compromise the safety of the subject, or the normal wound healing process:
• • 1. End-stage renal disease
• • 2. Immunosuppression
• • 3. Severe malnutrition
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