Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers

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.

Conditions

• Diabetic Foot Ulcer

Interventions

DEVICE

Dermal - Living Skin Replacement (Dermal - LSR)

Sponsors & Collaborators

• ApoPharma

  lead INDUSTRY

Principal Investigators

• Jason R Hanft, DPM, FAC FAS · Doctors Research Network, 7000 SW 62nd Avenue, Suite 310, South Miami, FL 33143

• Hau Pham, DPM · Foot Care Vascular and Endovascular Specialists of Boston Medical Center, 732 Harrison Ave., 2nd Floor, Boston, MA 02118

• Rodney Stuck, DPM · Hines VA Hospital, 5th and Roosevelt Rd., Building 200, 5th Floor, Room 501, Hines, IL 60141

• Vickie Driver, DPM · National Center for Lower Limb Preservation, 8816 Dempster Street, Niles, Il 60714

• Zevi Isseroff, DPM · North Shore Diabetic and Endocrine Associates, 3003 New Hyde Park Road Suite 201, New Hyde Park, NY, 11042

• Lowell Weil, Jr., DPM, MBA, FAC FAS · Weil Foot and Ankle Institute, 1455 Golf Rd., Suite 110, Golf-River Professional Building, Des Plaines, IL 60016

• Michal Drews · SPSK nr 2 im. H. Święcickiego AM Oddział Kliniczny Chirurgii Ogólnej Gastroenterologicznej i Endokrynologicznej ul. Przybyszewskiego 49

• Henryk Komon · Centrum Medyczno-Diagnostyczne Sp. z o.o. ul. Piłsudskiego 49 08-110 Siedlce Poland

• Krystyna Pilarska · SPWSZ w Szczecinie Klinika Endokrynologii, NadciśnieniaTętniczego i Chorób Przemiany Materii PAM ul. Arkońska 4 71-455 Szczecin

• Malgorzata Wilczynska · NZOZ Centrum Opieki Diabetologiczno-Endokrynologicznej ul. Karola Miarki 6 50-306 Wrocław Poland

• Joseph Cavorsi, M.D. · Center for Advanced Wound Care 640 Walnut St., Suite 302 Reading, PA 19601

• Roslyn R Isseroff, M.D. · Veterans Affairs Northern Health Care System

• Georgeanne Botek, DPM · The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40, Cleveland, OH 44195,

• Adam Landsman, DPM, PhD · Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road, Boston, MA 02215

• Jodi Walters, DPM · Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112), Tucson, AZ 85723

• Martin Taubman, DPM · San Diego Research Center 4452 Park Boulevard Suite 210, San Diego, CA 92116

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

84 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-02-28

Primary Completion

2007-09-30

Completion

2008-04-30

Countries

• United States

Study Locations