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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2006

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2009

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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