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

NCT02148302 | Terminated Results DMC

• 1 other identifier: CELLUTOME-VLU-013
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Impaired Wound Healing; Venous Insufficiency of Leg; Diabetic Ulcers

Keywords

Venous Leg Ulcerations; Epidermal Grafts; Chronic wounds; Clinical trial; Protease levels in chronic wounds

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Healed Wounds

  Number of patients experiencing wound healing with epidermal grafting and standard of care vs. standard of care alone

  12 weeks

Secondary Outcomes (3)

• Wound Area Change at Week 4

  4 weeks

• Wound Area Change at Week 12

  12 weeks

• Incidence of Adverse Event

  12 weeks

Study Arms (2)

Harvesting Device (CelluTome©)

EXPERIMENTAL

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©)

Control: SOC alone

NO INTERVENTION

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).

Interventions

Harvesting Device (CelluTome©) DEVICE

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.

Harvesting Device (CelluTome©)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old.
• 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®).
• 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.
• 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.
• Study ulcer is a minimum of 2.0 cm2 / maximum of 25 cm2 at the randomization visit.
• The target ulcer has been treated with compression therapy for at least 14 days prior to randomization.
• Ulcer has a clean, granulating base with minimal adherent slough at the randomization visit.
• Patient understands / is willing to participate in the clinical study and can comply with weekly visits and follow-up regimen.
• Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

You may not qualify if:

• Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.
• 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.
• Study ulcer exhibits clinical signs and symptoms of infection at the SV (screening visit) or TV1 (Treatment Visit 1).
• Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
• 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.
• 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.
• 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
• Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the course of the trial.
• Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded.
• Pregnant or breast feeding.
• Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history of Human Immunodeficiency Virus (HIV).
• Known uncontrolled Diabetes Mellitus, as measured by an HbA1c \> 10%.
• Ulcers that have healed more than 40% during the screening phase are excluded.
• 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.
• History of radiation at ulcer site.

Sponsors & Collaborators

• SerenaGroup, Inc.: lead
• Kinetic Concepts, Inc.: collaborator

Study Sites (18)

Eric Lullove, Dpm

Boca Raton, Florida, 33433, United States

Location

Advanced Research Institute of Miami

Homestead, Florida, 33030, United States

Location

Largo Medical Center

Largo, Florida, 33770, United States

Location

GF Professional Research

Miami Lakes, Florida, 33016, United States

Location

St Marys Health Care System

Athens, Georgia, 30606, United States

Location

Michael Miller, Do

Indianapolis, Indiana, 46234, United States

Location

Berkshire Medical Center

Pittsfield, Massachusetts, 01201, United States

Location

Inspira Health Network

Elmer, New Jersey, 08318, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Akron General Medical Center

Akron, Ohio, 44307, United States

Location

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

St John Medical Center

Tulsa, Oklahoma, 74135, United States

Location

Bay Area Hospital

Coos Bay, Oregon, 97420, United States

Location

Summit Health Hospital

Chambersburg, Pennsylvania, 17201, United States

Location

Saint Vincent Health Center

Erie, Pennsylvania, 16544, United States

Location

Armstrong County Memorial Hospital

Kittanning, Pennsylvania, 16201, United States

Location

Regional Medical Center

Orangeburg, South Carolina, 29118, United States

Location

Pharmakon Medical Research

Harrisonburg, Virginia, 22801, United States

Location

Limitations and Caveats

The study was terminated before protocol enrollment could be reached.

Results Point of Contact

• Title: Thomas E. Serena, MD
• Organization: SerenaGroup

serena@serenagroups.com

617-945-5225

Study Officials

• Thomas Serena, MD

  SerenaGroup, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: May 28, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 29, 2020
• Results First Posted: April 29, 2020

Record last verified: 2020-04

Locations

US (18)