Clinical Trial to Evaluate Blister Graft Utilizing a Novel Harvesting Device for Treatment of Venous Leg Ulcers
Public ClinicalTrials.gov record NCT02148302. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02148302
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 123 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2014
- Primary completion
- Oct 31, 2017
- Completion
- Oct 31, 2017
- Last update posted
- Apr 28, 2020
2014 – 2017
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Eric Lullove, Dpm | Boca Raton | Florida | 33433 | — |
| Advanced Research Institute of Miami | Homestead | Florida | 33030 | — |
| Largo Medical Center | Largo | Florida | 33770 | — |
| GF Professional Research | Miami Lakes | Florida | 33016 | — |
| St Marys Health Care System | Athens | Georgia | 30606 | — |
| Michael Miller, Do | Indianapolis | Indiana | 46234 | — |
| Berkshire Medical Center | Pittsfield | Massachusetts | 01201 | — |
| Inspira Health Network | Elmer | New Jersey | 08318 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Akron General Medical Center | Akron | Ohio | 44307 | — |
| University of Toledo Medical Center | Toledo | Ohio | 43614 | — |
| St John Medical Center | Tulsa | Oklahoma | 74135 | — |
| Bay Area Hospital | Coos Bay | Oregon | 97420 | — |
| Summit Health Hospital | Chambersburg | Pennsylvania | 17201 | — |
| Saint Vincent Health Center | Erie | Pennsylvania | 16544 | — |
| Armstrong County Memorial Hospital | Kittanning | Pennsylvania | 16201 | — |
| Regional Medical Center | Orangeburg | South Carolina | 29118 | — |
| Pharmakon Medical Research | Harrisonburg | Virginia | 22801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02148302, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 28, 2020 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02148302 live on ClinicalTrials.gov.