Clinical Trial to Evaluate Blister Graft Utilizing a Novel Harvesting Device for Treatment of Venous Leg Ulcers (Cellutome)
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|ClinicalTrials.gov Identifier: NCT02148302|
Recruitment Status : Terminated (Stopped by sponsor. No interest in continuing trial due to business changes.)
First Posted : May 28, 2014
Last Update Posted : September 10, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Impaired Wound Healing Venous Insufficiency of Leg Diabetic Ulcers||Device: Harvesting Device (CelluTome©)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
Experimental: Harvesting Device (CelluTome©)
open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers.
Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8.
A run-in period of two weeks followed by twelve weeks of active treatment
Device: Harvesting Device (CelluTome©)
Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone.
No Intervention: Control: SOC alone
The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN).
- Time to healing in patients treated with epidermal grafting and standard of care vs. standard of care alone. [ Time Frame: 12 weeks ]
- Percentage of venous leg ulcers that have healed each week. [ Time Frame: 12 weeks ]
- Cost effectiveness of epidermal grafting versus standard of care. [ Time Frame: 12 weeks ]
- Incidence of adverse events with epidermal grafting versus standard of care. [ Time Frame: 12 weeks ]
- Correlation between protease level and healing rate. [ Time Frame: 12 weeks ]Swabs will be collected on the ulcer to determine the protease level. This level will be correlated with the healing process as indicated by wound characteristics and wound size.
- Pain scores as reported by subjects. [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148302
|United States, Florida|
|Eric Lullove, Dpm|
|Boca Raton, Florida, United States, 33433|
|Advanced Research Institute of Miami|
|Homestead, Florida, United States, 33030|
|Largo Medical Center|
|Largo, Florida, United States, 33770|
|GF Professional Research|
|Miami Lakes, Florida, United States, 33016|
|United States, Georgia|
|St Marys Health Care System|
|Athens, Georgia, United States, 30606|
|United States, Indiana|
|Michael Miller, Do|
|Indianapolis, Indiana, United States, 46234|
|United States, Massachusetts|
|Berkshire Medical Center|
|Pittsfield, Massachusetts, United States, 01201|
|United States, New Jersey|
|Inspira Health Network|
|Elmer, New Jersey, United States, 08318|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, Ohio|
|Akron General Medical Center|
|Akron, Ohio, United States, 44307|
|University of Toledo Medical Center|
|Toledo, Ohio, United States, 43614|
|United States, Oklahoma|
|St John Medical Center|
|Tulsa, Oklahoma, United States, 74135|
|United States, Oregon|
|Bay Area Hospital|
|Coos Bay, Oregon, United States, 97420|
|United States, Pennsylvania|
|Summit Health Hospital|
|Chambersburg, Pennsylvania, United States, 17201|
|Saint Vincent Health Center|
|Erie, Pennsylvania, United States, 16544|
|Armstrong County Memorial Hospital|
|Kittanning, Pennsylvania, United States, 16201|
|United States, South Carolina|
|Regional Medical Center|
|Orangeburg, South Carolina, United States, 29118|
|United States, Virginia|
|Pharmakon Medical Research|
|Harrisonburg, Virginia, United States, 22801|
|Principal Investigator:||Thomas Serena, MD||SerenaGroup, Inc.|