Clinical Trial to Evaluate Blister Graft Utilizing a Novel Harvesting Device for Treatment of Venous Leg Ulcers — Cellutome  

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

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Blister
• Diabetic Ulcers
• Impaired Wound Healing
• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Insufficiency
• Venous Insufficiency of Leg

• NCT number: NCT02148302
• Study type: Interventional
• Source: SerenaGroup, Inc.
• Status: Terminated
• Phase: N/A
• Start date: May 2014
• Completion date: November 2017