Recruiting
Phase 2

KC002

Sponsor:

KeraCure

Code:

NCT00330265

Conditions

Foot Ulcer

Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KC-002

Conventional Wound Therapy

Study Details

Brief summary:

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.

Conditions

Foot Ulcer

Diabetes

Study ID

NCT00330265

Start date

Jan, 2006

Status verified date

Aug, 2008

Completion date

Sep, 2009

Anticipated

Primary completion date

Mar, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

KC-002

other: 2

Conventional Wound Therapy

Interventions

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.

Conventional Wound Therapy

Normal Saline Dressings

Primary outcome measure

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

Central Contacts and Locations

Central contacts

M Meek

866-537-2287clinicaltrial@keracure.com

Locations

Institute for Advanced Wound Care at Baptist Medical Center South

Recruiting

Montgomery, Alabama, United States, 36111

Contacts

334-286-3444

HOPE Research Institute

Recruiting

Phoenix, Arizona, United States, 85050

Contacts

602-274-4100

Southern Arizona VA Health Care System

Recruiting

Tucson, Arizona, United States, 85723

Contacts

520-792-1450

Roy Kroeker, DPM

Recruiting

Fresno, California, United States, 93710

Contacts

559-436-8162

Felix Sigal, DPM

Recruiting

Los Angeles, California, United States, 90010

Contacts

888-860-4325

Bay Area Foot Care

Recruiting

San Francisco, California, United States, 94115

Contacts

415-292-0638

North American Center for Limb Preservation

Recruiting

New Haven, Connecticut, United States, 06515

Contacts

203-397-0624

Georgetown University / Wound Healing Center

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

202-444-1784

Doctor's Research Network

Recruiting

South Miami, Florida, United States, 33143

Contacts

305-662-1444

Medical Associates

Recruiting

Clinton, Iowa, United States, 52732

Contacts

563-519-1871

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

410-601-5106

Preston Family Building

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

617-414-6840

Foot Healthcare Associates, PC

Recruiting

Livonia, Michigan, United States, 48152

Contacts

734-542-9305

St. Vincent Health Center Wound Clinic

Recruiting

Erie, Pennsylvania, United States, 16444

Contacts

814-452-7878

Pivotal Clinical Research

Recruiting

Souderton, Pennsylvania, United States, 18964

Contacts

215-723-7121

Warren General Hospital Wound Clinic

Recruiting

Warren, Pennsylvania, United States, 16365

Contacts

814-723-3300

Martin Foot and Ankle

Recruiting

York, Pennsylvania, United States, 17403

Contacts

717-718-0216

San Antonio Podiatry Associates, PC

Recruiting

San Antonio, Texas, United States, 78229

Contacts

210-949-0807

Pharmaceutical Research Organization

Recruiting

Bountiful, Utah, United States, 84010

Contacts

801-294-9911

Dixie Regional Medical Center's Wound Clinic

Recruiting

St. George, Utah, United States, 84770

Contacts

435-688-5281

Central Washington Podiatry Service

Recruiting

Yakima, Washington, United States, 98902

Contacts

509-248-2900

More Information

Sponsor

KeraCure

Last update posted

Aug 26, 2008

Last verified

Aug, 2008

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by KeraCure on 2008-08-26.