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 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 Start Date
Estimated Completion Date
- Device: Harvesting Device (CelluTomeÂ©)
- Device: Harvesting Device (CelluTome©)
- Cardiology: Vascular Medicine
- Surgery: Vascular
- Harvesting Device
- Leg Ulcer
- Venous Insufficiency
SerenaGroup, Inc. -- CELLUTOME-VLU-013
1. At least 18 years old.
2. Adequate arterial flow (Ankle Brachial Pressure Index (ABI) > 0.75. (Calculations
will be made using measurements from both posterior tibial and dorsalis pedis
arteries as well as both arms), OR Skin Perfusion Pressure (SPP) >30, OR biphasic PVR
OR TBI > 0.60 OR TCPO2 > 30mmHg OR adequate perfusion as demonstrated on florescent
3. Presence of a venous leg ulcer through full skin thickness but not down to muscle,
tendon or bone. The largest ulcer will be the index ulcer and the only one included
in the study. If other ulcerations are present on the same leg they have to be more
than 2 cm apart from the index ulcer.
4. Study ulcer has been present for at least one month prior to the initial screening
visit, and is excluded if it has undergone 12 months of continuous high strength
compression therapy over its duration.
5. Study ulcer is a minimum of 3.5 cm2 / maximum of 25 cm2 at the randomization visit.
6. Venous Duplex exam confirms venous insufficiency as defined by reflux of greater than
or equal to 0.5sec.
7. The target ulcer has been treated with compression therapy for at least 14 days prior
8. Ulcer has a clean, granulating base with minimal adherent slough at the randomization
9. Patient understands / is willing to participate in the clinical study and can comply
with weekly visits and follow-up regimen.
10. Patient has read and signed the IRB/IEC approved Informed Consent Form before
screening procedures are undertaken.
Potential subjects meeting any of the following criteria will be excluded from enrollment
and subsequent randomization.
1. Study ulcer(s) deemed by the investigator to be caused by a medical condition other
than venous insufficiency. These may include, but are not limited to: fungal
ulcerations, malignant ulcerations, and ulcerations due to arterial insufficiency.
2. Study ulcer exhibits clinical signs and symptoms of infection at the SV (screening
visit) or TV1 (Treatment Visit 1).
3. Known allergy to the components of the multi-layer compression bandaging, or who
cannot tolerate multi-layer compression therapy.
4. Study ulcer is suspicious for cancer should undergo an ulcer biopsy to rule out a
carcinoma of the ulcer. The patient may be enrolled after a negative biopsy.
5. Patients with a history of more than two weeks treatment with immunosuppressants
(including systemic corticosteroids), cytotoxic chemotherapy, or application of
topical steroids to the ulcer surface within one month prior to initial screening, or
who receive such medications during the screening period, or who are anticipated to
require such medications during the course of the study.
6. Study ulcer has been previously treated with tissue engineered materials (e.g.
Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, meristem) within
the last 30 days
7. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the
course of the trial.
8. Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the
malleolus are excluded.
9. Pregnant or breast feeding.
10. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history
of Human Immunodeficiency Virus (HIV).
11. Known uncontrolled Diabetes Mellitus, as measured by an HbA1c > 10%.
12. Ulcers that have healed more than 40% during the screening phase are excluded.
13. Patients on any investigational drug(s) or therapeutic device(s) within 30 days
preceding screening (i.e. S1) or patient or physician anticipates use of any of
these therapies by the subject during the course of the study.
14. History of radiation at ulcer site.
15. Presence of one or more medical conditions, including renal, hepatic, hematologic,
active auto-immune or immune diseases that, would make the subject an inappropriate
candidate for this ulcer healing study.
16. Patients who are unable to understand the aims and objectives of the trial.
17. Presence of any condition(s) which seriously compromises the subject's ability to
complete this study, or has a known history of poor adherence with medical treatment.
18 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (19)
|Hackensack University Medical Center - Hackensack, New Jersey||47.6 miles||Rummana Aslam MD||408-833-8288||None|
|Berkshire Medical Center - Pittsfield, Massachusetts||85.7 miles||Richard Basile MD||413-347-4767||None|
|Inspira Health Network - Elmer, New Jersey||153.1 miles||Cristina Nituica MD||856-363-1575||None|
|Summit Health Hospital - Chambersburg, Pennsylvania||249.1 miles||David Guthrie MD||717-267-7715||None|
|Armstrong County Memorial Hospital - Kittanning, Pennsylvania||329.1 miles||Keyur Patel MD||724-543-8893||None|
|Pharmakon Medical Research - Harrisonburg, Virginia||355.4 miles||Orlando Cedeno DPM||540-217-5610||None|
|Saint Vincent Health Center - Erie, Pennsylvania||359.8 miles||None||None||None|
|Akron General Medical Center - Akron, Ohio||432.6 miles||None||None||None|
|University of Toledo Medical Center - Toledo, Ohio||539.5 miles||Munier Nazzal MD||419-383-6810||None|
|Regional Medical Center - Orangeburg, South Carolina||677.3 miles||John Samies MD||803-395-2826||None|
|Michael Miller Do - Indianapolis, Indiana||695.4 miles||None||None||None|
|St Marys Health Care System - Athens, Georgia||750.9 miles||None||None||None|
|Largo Medical Center - Largo, Florida||1,068.5 miles||Karen Kritsky DO||727-587-7598||None|
|Eric Lullove Dpm - Boca Raton, Florida||1,103.3 miles||None||None||None|
|Amun Medical Research - North Miami, Florida||1,132.2 miles||Sophia Deben MD||305-226-0087||None|
|GF Professional Research - Miami Lakes, Florida||1,137.0 miles||Gary Keller DPM||305-821-1000||None|
|Advanced Research Institute of Miami - Homestead, Florida||1,167.1 miles||Juliette Perez DPM||305-246-0001||None|
|St John Medical Center - Tulsa, Oklahoma||1,272.5 miles||Lam Le MD||918-712-3377||None|
|Bay Area Hospital - Coos Bay, Oregon||2,576.3 miles||Robert Hunter MD||541-269-4180||None|