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NCT02148302 · ClinicalTrials.gov registry record · NA
Clinical Trial to Evaluate Blister Graft Utilizing a Novel Harvesting Device for Treatment of Venous Leg Ulcers
A NA study, sponsored by SerenaGroup.
- Terminated
- Registry status
- NA
- Development phase
- 123
- Enrollment target
NCT02148302 is a NA study that was terminated before completion, run by SerenaGroup. The registered enrollment target is 123 participants.
The verdict
NCT02148302, a NA study, was terminated before completion, sponsored by SerenaGroup.
- TERMINATED
- Registry status
- NA
- Development phase
- 123 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Harvesting Device (CelluTome©)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02148302
The ClinicalTrials.gov registry entry for NCT02148302 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SerenaGroup, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Harvesting Device (CelluTome©) is the first listed.
NCT02148302 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02148302 about?
NCT02148302 is a clinical study titled "Clinical Trial to Evaluate Blister Graft Utilizing a Novel Harvesting Device for 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 grafti...
What is the current status of trial NCT02148302?
This trial is currently terminated. It is a NA study. The enrollment target is 123 participants. The study started on 2014-05. Estimated completion is 2017-11.
What interventions are being tested in trial NCT02148302?
The interventions under investigation include: Harvesting Device (CelluTome©) (DEVICE).
Who is sponsoring clinical trial NCT02148302?
This trial is sponsored by SerenaGroup, which has 10 total clinical trials registered on ClinicalTrials.gov.
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