Pivotal Study to Evaluate the Efficacy and Safety of Dermal-Living Skin Replacement (Dermal-LSR) in the Treatment of Chronic Diabetic Foot Ulcers

Status: Terminated
Location: See all (12) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 84
Healthy Volunteers: No
View:

• Has signed a written informed consent prior to the first study intervention

• Is at least 18 and <85 years of age

• Has one or more diabetic foot ulcers on the target limb, with only one marked for the study (target ulcer). It must have the following characteristics:Plantar; Grade 2 per Curative Health Services Classification; Non-infected; Neuropathic; Non-malignant; At least 1.0-25cm^2 post-debridement; Present for at least 6 weeks

• Has Type I or II Diabetes Mellitus with an HBA1c between 6-10%

• Has a maximum fasting blood glucose level of 13.8 mmol/L

• An ankle-brachial systolic pressure index between 0.7 and 1.3

• If female and of childbearing potential has a negative serum pregnancy test and is neither breastfeeding or intending to become pregnant during the study

• Able and willing to attend the scheduled visits and comply with study procedures.

Locations
United States
Arizona
Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112)
Tuscon
California
Veterans Affairs Northern Health Care System, Sacramento VA Medical Center at Mather
Mather
San Diego Research Center 4452 Park Boulevard Suite 210, San Diego
San Diego
Florida
Doctors Research Network
South Miami
Illinois
Weil Foot and Ankle Institute
Des Plaines
Hines VA Hospital
Hines
National Center for Lower Limb Preservation
Niles
Massachusetts
Foot Care Vascular and Endovascular Specialists of Boston Medical Center
Boston
Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road
Boston
New York
North Shore Diabetic and Endocrine Associates
New Hyde Park
Ohio
The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40
Cleveland
Pennsylvania
Center for Advanced Wound Care
Reading
Time Frame
Start Date: February 2006
Completion Date: April 2008
Participants
Target number of participants: 288
Authors
Hau Pham, Vickie Driver, Lowell Weil, Rodney Stuck, Jason R Hanft, Zevi Isseroff, Adam Landsman, Joseph Cavorsi, Jodi Walters, Roslyn R Isseroff, Georgeanne Botek, Krystyna Pilarska, Martin Taubman, Henryk Komon, Malgorzata Wilczynska, Michal Drews
Sponsors
Leads: ApoPharma

This content was sourced from clinicaltrials.gov

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