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

April 30, 2008 updated by: ApoPharma

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study is a pivotal, prospective, randomized, controlled, open-label, multi-center study that will evaluate the effectiveness and safety of topically applied Dermal-LSR in chronic DFUs.

Study Type

Interventional

Enrollment (Anticipated)

288

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tuscon, Arizona, United States, 85723
        • Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112)
    • California
      • Mather, California, United States, 95655
        • Veterans Affairs Northern Health Care System, Sacramento VA Medical Center at Mather
      • San Diego, California, United States, 92116
        • San Diego Research Center 4452 Park Boulevard Suite 210, San Diego
    • Florida
      • South Miami, Florida, United States, 33143
        • Doctors Research Network
    • Illinois
      • Des Plaines, Illinois, United States, 60016
        • Weil Foot and Ankle Institute
      • Hines, Illinois, United States, 60141
        • Hines VA Hospital
      • Niles, Illinois, United States, 60714
        • National Center for Lower Limb Preservation
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Foot Care Vascular and Endovascular Specialists of Boston Medical Center
      • Boston, Massachusetts, United States, 02215
        • Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road
    • New York
      • New Hyde Park, New York, United States, 11042
        • North Shore Diabetic and Endocrine Associates
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40
    • Pennsylvania
      • Reading, Pennsylvania, United States, 19601
        • Center for Advanced Wound Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Known or suspected disease of the immune system
  • Active or untreated malignancy or active, uncontrolled connective tissue disease
  • Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment
  • Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
  • Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to enrollment
  • Active febrile illness
  • AST, ALT, ALP >3x the normal upper limit
  • Serum Creatinine >2x the normal upper limit
  • Osteomyelitis
  • Active Charcot
  • Use of any topical treatments other than SOC (standard of care)at the time of enrollment
  • Enrollment in any investigational clinical trial within 30 days of the screening visit
  • Known or suspected hypersensitivity to any study product components
  • Recent or current history of alcohol or drug abuse
  • Any condition, which in the opinion of the Investigator, would interfere with the evaluation of the study product or poses a health risk to the subject
  • All site personnel directly affiliated with this study and their immediate families

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the efficacy and safety of Dermal-LSR plus Standard of Care (SOC) for the treatment of chronic diabetic foot ulcers in comparison to treatment with SOC alone.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ApoPharma

Investigators

  • Principal Investigator: Jason R Hanft, DPM, FAC FAS, Doctors Research Network, 7000 SW 62nd Avenue, Suite 310, South Miami, FL 33143
  • Principal Investigator: Hau Pham, DPM, Foot Care Vascular and Endovascular Specialists of Boston Medical Center, 732 Harrison Ave., 2nd Floor, Boston, MA 02118
  • Principal Investigator: Rodney Stuck, DPM, Hines VA Hospital, 5th and Roosevelt Rd., Building 200, 5th Floor, Room 501, Hines, IL 60141
  • Principal Investigator: Vickie Driver, DPM, National Center for Lower Limb Preservation, 8816 Dempster Street, Niles, Il 60714
  • Principal Investigator: Zevi Isseroff, DPM, North Shore Diabetic and Endocrine Associates, 3003 New Hyde Park Road Suite 201, New Hyde Park, NY, 11042
  • Principal Investigator: 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
  • Principal Investigator: Michal Drews, SPSK nr 2 im. H. Święcickiego AM Oddział Kliniczny Chirurgii Ogólnej Gastroenterologicznej i Endokrynologicznej ul. Przybyszewskiego 49
  • Principal Investigator: Henryk Komon, Centrum Medyczno-Diagnostyczne Sp. z o.o. ul. Piłsudskiego 49 08-110 Siedlce Poland
  • Principal Investigator: Krystyna Pilarska, SPWSZ w Szczecinie Klinika Endokrynologii, NadciśnieniaTętniczego i Chorób Przemiany Materii PAM ul. Arkońska 4 71-455 Szczecin
  • Principal Investigator: Malgorzata Wilczynska, NZOZ Centrum Opieki Diabetologiczno-Endokrynologicznej ul. Karola Miarki 6 50-306 Wrocław Poland
  • Principal Investigator: Joseph Cavorsi, M.D., Center for Advanced Wound Care 640 Walnut St., Suite 302 Reading, PA 19601
  • Principal Investigator: Roslyn R Isseroff, M.D., Veterans Affairs Northern Health Care System
  • Principal Investigator: Georgeanne Botek, DPM, The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40, Cleveland, OH 44195,
  • Principal Investigator: Adam Landsman, DPM, PhD, Joslin-Beth Israel Deaconess Foot Center, Division of Podiatry, 185 Pilgrim Road, Boston, MA 02215
  • Principal Investigator: Jodi Walters, DPM, Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112), Tucson, AZ 85723
  • Principal Investigator: Martin Taubman, DPM, San Diego Research Center 4452 Park Boulevard Suite 210, San Diego, CA 92116

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

October 10, 2006

First Submitted That Met QC Criteria

October 10, 2006

First Posted (Estimate)

October 12, 2006

Study Record Updates

Last Update Posted (Estimate)

May 2, 2008

Last Update Submitted That Met QC Criteria

April 30, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS03-2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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