Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers (KC-002PT)

August 25, 2008 updated by: KeraCure

A Prospective, Randomized, Controlled, Unmasked, Multiple Treatment, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of an Interactive Wound Dressing Containing Cultured Keratinocytes Versus Conventional Wound Therapy for the Treatment of Diabetic Foot Ulcers

The objective of this study is to determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus.

This is a prospective, randomized, multi-center, unmasked, controlled study. All patients will receive care for the diabetic foot ulcer during the study.

Participation in the study is for 24 weeks.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

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
    • Alabama
      • Montgomery, Alabama, United States, 36111
        • Recruiting
        • Institute for Advanced Wound Care at Baptist Medical Center South
        • Contact:
          • Phone Number: 334-286-3444
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • Recruiting
        • HOPE Research Institute
        • Contact:
          • Phone Number: 602-274-4100
      • Tucson, Arizona, United States, 85723
        • Recruiting
        • Southern Arizona VA Health Care System
        • Contact:
          • Phone Number: 520-792-1450
    • California
      • Fresno, California, United States, 93710
        • Recruiting
        • Roy Kroeker, DPM
        • Contact:
          • Phone Number: 559-436-8162
      • Los Angeles, California, United States, 90010
        • Recruiting
        • Felix Sigal, DPM
        • Contact:
          • Phone Number: 888-860-4325
      • San Francisco, California, United States, 94115
        • Recruiting
        • Bay Area Foot Care
        • Contact:
          • Phone Number: 415-292-0638
    • Connecticut
      • New Haven, Connecticut, United States, 06515
        • Recruiting
        • North American Center for Limb Preservation
        • Contact:
          • Phone Number: 203-397-0624
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University / Wound Healing Center
        • Contact:
          • Phone Number: 202-444-1784
    • Florida
      • South Miami, Florida, United States, 33143
        • Recruiting
        • Doctor's Research Network
        • Contact:
          • Phone Number: 305-662-1444
    • Iowa
      • Clinton, Iowa, United States, 52732
        • Recruiting
        • Medical Associates
        • Contact:
          • Phone Number: 563-519-1871
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Contact:
          • Phone Number: 410-601-5106
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Preston Family Building
        • Contact:
          • Phone Number: 617-414-6840
    • Michigan
      • Livonia, Michigan, United States, 48152
        • Recruiting
        • Foot Healthcare Associates, PC
        • Contact:
          • Phone Number: 734-542-9305
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16444
        • Recruiting
        • St. Vincent Health Center Wound Clinic
        • Contact:
          • Phone Number: 814-452-7878
      • Souderton, Pennsylvania, United States, 18964
        • Recruiting
        • Pivotal Clinical Research
        • Contact:
          • Phone Number: 215-723-7121
      • Warren, Pennsylvania, United States, 16365
        • Recruiting
        • Warren General Hospital Wound Clinic
        • Contact:
          • Phone Number: 2752 814-723-3300
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Martin Foot and Ankle
        • Contact:
          • Phone Number: 717-718-0216
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • San Antonio Podiatry Associates, PC
        • Contact:
          • Phone Number: 210-949-0807
    • Utah
      • Bountiful, Utah, United States, 84010
        • Recruiting
        • Pharmaceutical Research Organization
        • Contact:
          • Phone Number: 801-294-9911
      • St. George, Utah, United States, 84770
        • Recruiting
        • Dixie Regional Medical Center's Wound Clinic
        • Contact:
          • Phone Number: 435-688-5281
    • Washington
      • Yakima, Washington, United States, 98902
        • Recruiting
        • Central Washington Podiatry Service
        • Contact:
          • Phone Number: 509-248-2900

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants included in the study must:

  • Have Type 1 or Type 2 diabetes mellitus
  • Have a diabetic foot ulcer on the bottom of the foot or heal which has been present for three (3) weeks but less than two (2) years and is sufficient size to qualify for the study
  • Be able to visit the study doctor regularly for 24 weeks

Exclusion Criteria:

Participants may not be included if:

  • The diabetic foot ulcer is infected
  • They have poor circulation in their study foot
  • Cannot or will not wear a special boot to take pressure off the study ulcer
  • They have certain other diseases or laboratory values which are not within a specified range

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
KC-002
Device: KC-002
Determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus.
Other: 2
Conventional Wound Therapy
Other: Conventional Wound Therapy
Normal Saline Dressings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

KeraCure

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

January 1, 2006

Primary Completion (Anticipated)

March 1, 2009

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

May 24, 2006

First Submitted That Met QC Criteria

May 24, 2006

First Posted (Estimate)

May 26, 2006

Study Record Updates

Last Update Posted (Estimate)

August 26, 2008

Last Update Submitted That Met QC Criteria

August 25, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT 20051320

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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