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

Diabetes Clinical Trial

— KC-002PT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00330265
• Other study ID #: NCT 20051320
• Status: Recruiting
• Phase: Phase 2
• First received: May 24, 2006
• Last updated: August 25, 2008
• Start date: January 2006
• Est. completion date: September 2009

Study information

• Verified date: August 2008
• Source: KeraCure
• Contact: M Meek
• Phone: 866-537-2287
• Email: clinicaltrial[@]keracure.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetic Foot
• Foot Ulcer
• Ulcer

Intervention

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:
• Conventional Wound Therapy
Normal Saline Dressings

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Preston Family Building	Boston	Massachusetts
United States	Pharmaceutical Research Organization	Bountiful	Utah
United States	Medical Associates	Clinton	Iowa
United States	St. Vincent Health Center Wound Clinic	Erie	Pennsylvania
United States	Roy Kroeker, DPM	Fresno	California
United States	Foot Healthcare Associates, PC	Livonia	Michigan
United States	Felix Sigal, DPM	Los Angeles	California
United States	Institute for Advanced Wound Care at Baptist Medical Center South	Montgomery	Alabama
United States	North American Center for Limb Preservation	New Haven	Connecticut
United States	HOPE Research Institute	Phoenix	Arizona
United States	San Antonio Podiatry Associates, PC	San Antonio	Texas
United States	Bay Area Foot Care	San Francisco	California
United States	Pivotal Clinical Research	Souderton	Pennsylvania
United States	Doctor's Research Network	South Miami	Florida
United States	Dixie Regional Medical Center's Wound Clinic	St. George	Utah
United States	Southern Arizona VA Health Care System	Tucson	Arizona
United States	Warren General Hospital Wound Clinic	Warren	Pennsylvania
United States	Georgetown University / Wound Healing Center	Washington	District of Columbia
United States	Central Washington Podiatry Service	Yakima	Washington
United States	Martin Foot and Ankle	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
KeraCure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment		12 weeks	No