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

Description

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

May 2014

Estimated Completion Date

May 2016

Interventions

  • Device: Harvesting Device (CelluTome©)
  • Device: Harvesting Device (CelluTome©)

Specialties

  • Cardiology: Vascular Medicine
  • Surgery: Vascular

MeSH Terms

  • Harvesting Device
  • Leg Ulcer
  • Venous Insufficiency

Study ID

SerenaGroup, Inc. -- CELLUTOME-VLU-013

Status

Unknown

Trial ID

NCT02148302

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

194

Sponsor

SerenaGroup, Inc.

Inclusion Criteria

    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 angiography, LUNA®). 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 to randomization. 8. Ulcer has a clean, granulating base with minimal adherent slough at the randomization visit. 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.

Exclusion Criteria

    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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (19)

Study Location Distance Name Phone Email
Berkshire Medical Center - Pittsfield, Massachusetts 109.9 miles Richard Basile MD 413-347-4767 None
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles Rummana Aslam MD 408-833-8288 None
Inspira Health Network - Elmer, New Jersey 288.1 miles Cristina Nituica MD 856-363-1575 None
Summit Health Hospital - Chambersburg, Pennsylvania 381.7 miles David Guthrie MD 717-267-7715 None
Armstrong County Memorial Hospital - Kittanning, Pennsylvania 449.1 miles Keyur Patel MD 724-543-8893 None
Saint Vincent Health Center - Erie, Pennsylvania 461.6 miles None None None
Pharmakon Medical Research - Harrisonburg, Virginia 491.4 miles Orlando Cedeno DPM 540-217-5610 None
Akron General Medical Center - Akron, Ohio 546.9 miles None None None
University of Toledo Medical Center - Toledo, Ohio 646.5 miles Munier Nazzal MD 419-383-6810 None
Regional Medical Center - Orangeburg, South Carolina 810.8 miles John Samies MD 803-395-2826 None
Michael Miller Do - Indianapolis, Indiana 813.7 miles None None None
St Marys Health Care System - Athens, Georgia 887.2 miles None None None
Largo Medical Center - Largo, Florida 1,197.4 miles Karen Kritsky DO 727-587-7598 None
Eric Lullove Dpm - Boca Raton, Florida 1,222.7 miles None None None
Amun Medical Research - North Miami, Florida 1,250.9 miles Sophia Deben MD 305-226-0087 None
GF Professional Research - Miami Lakes, Florida 1,256.3 miles Gary Keller DPM 305-821-1000 None
Advanced Research Institute of Miami - Homestead, Florida 1,286.5 miles Juliette Perez DPM 305-246-0001 None
St John Medical Center - Tulsa, Oklahoma 1,394.8 miles Lam Le MD 918-712-3377 None
Bay Area Hospital - Coos Bay, Oregon 2,652.5 miles Robert Hunter MD 541-269-4180 None

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