Venous Insufficiency of Leg Clinical Trial
Official title:
A Multi-center Randomized Open-Label Controlled Clinical Trial Evaluating Suction Blister Grafting Utilizing a Novel Harvesting Device (CelluTome©) and Standard of Care vs. Standard of Care Alone in the Treatment of Venous Leg Ulcers
Epidermal grafts are believed to promote healing by two mechanisms: graft take and the
promotion of wound healing through the delivery of growth factors and the essential elements
of tissue repair and wound healing.28 This study is intended to establish the superior
effectiveness of epidermal grafting and multi-layer compression over that of multi-layer
compression alone, in the treatment of venous leg ulcers.
Millions of Americans are afflicted with painful, open, draining sores on their lower
extremities. These sores are referred to as venous leg ulcerations (VLUs). Under the best of
circumstances these ulcers require weeks or months to heal. Not uncommonly wound care
specialists see patients who have suffered for years or faced amputation of the limb as their
only option to alleviate the pain.
Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However,
roughly half of patients suffering from venous ulcers will require advanced therapy.
Epidermal grafting has been a reconstructive option for decades; however, to date there has
not been a reliable and reproducible system to harvest epidermis. The CelluTome® Harvesting
System permits the harvesting of epidermal blister grafts at the patient's bedside without
the need for anesthesia. The grafts can be easily transferred to the wound bed. In case
studies, epidermal grafting appeared to be effective in reducing wound size and accelerating
closure of venous leg ulcers.
This study is a multi-center, randomized, controlled open-label study designed to evaluate
the safety and effectiveness of epidermal grafting using the CelluTome® system plus
multi-layer compression therapy versus multi-layer compression (SOC) in the treatment of
venous leg ulcers.
The study will have two phases: Screening and Treatment. The Screening Phase (1 -14 days) is
designed to determine whether subjects are eligible to proceed to the Treatment Phase of the
study and consists of a series of screening assessments designed to determine eligibility.
At or up to 14 days before the first Screening Phase Visit (S1), written informed consent
from the subject will be obtained by the Investigator or suitably qualified designee before
the performance of any other protocol-specific procedure.
At the first Screening Phase Visit (S1), the Investigator will select the study (target)
ulcer. Each subject will have only one VLU selected as the study (target) ulcer. In the
situation where a subject has more than one VLU at the S1 visit, the Investigator will select
the largest VLU that meets the eligibility criteria of the protocol as the study (target)
ulcer.
Patients whose target ulcer has been treated with compression therapy for the previous two
weeks are eligible to enter the treatment phase once all of the inclusion and exclusion
criteria are met. If the ulcer has not received compression, the patient should be placed in
compression and enrolled in the study after 14 days of compression therapy. Ulcers that have
decreased in size by more than 40% during the screening period will be excluded as "rapid
healer." Subjects that meet the inclusion/exclusion criteria at the end of screening will be
randomized to either the Cellutome graft plus Standard of Care group or just the Standard of
Care group. At Treatment Visit 7, subjects in the Standard of Care group that have healed
<40% will be allowed to cross over to the Cellutome graft group.
The study will consist of up to 30 centers in the United States each contributing about 10
subjects per center in order to obtain 194 evaluable subjects. The investigators anticipate a
10% drop out rate during the trial therefore a total of 213 subjects will be recruited. This
trial employs an adaptive design therefore the enrollment numbers may be reduced or increased
based on planned interim analysis.
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