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

Sponsor

KeraCure (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00330265

Collaborator

(none)

300

Enrollment

Locations

Arms

Duration (Months)

14.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Foot Ulcer Diabetes	Device: KC-002 Other: Conventional Wound Therapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2006

Anticipated Primary Completion Date :

Mar 1, 2009

Anticipated Study Completion Date :

Sep 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Advanced Wound Care at Baptist Medical Center South	Montgomery	Alabama	United States	36111
2	HOPE Research Institute	Phoenix	Arizona	United States	85050
3	Southern Arizona VA Health Care System	Tucson	Arizona	United States	85723
4	Roy Kroeker, DPM	Fresno	California	United States	93710
5	Felix Sigal, DPM	Los Angeles	California	United States	90010
6	Bay Area Foot Care	San Francisco	California	United States	94115
7	North American Center for Limb Preservation	New Haven	Connecticut	United States	06515
8	Georgetown University / Wound Healing Center	Washington	District of Columbia	United States	20007
9	Doctor's Research Network	South Miami	Florida	United States	33143
10	Medical Associates	Clinton	Iowa	United States	52732
11	Sinai Hospital of Baltimore	Baltimore	Maryland	United States	21215
12	Preston Family Building	Boston	Massachusetts	United States	02118
13	Foot Healthcare Associates, PC	Livonia	Michigan	United States	48152
14	St. Vincent Health Center Wound Clinic	Erie	Pennsylvania	United States	16444
15	Pivotal Clinical Research	Souderton	Pennsylvania	United States	18964
16	Warren General Hospital Wound Clinic	Warren	Pennsylvania	United States	16365
17	Martin Foot and Ankle	York	Pennsylvania	United States	17403
18	San Antonio Podiatry Associates, PC	San Antonio	Texas	United States	78229
19	Pharmaceutical Research Organization	Bountiful	Utah	United States	84010
20	Dixie Regional Medical Center's Wound Clinic	St. George	Utah	United States	84770
21	Central Washington Podiatry Service	Yakima	Washington	United States	98902

Sponsors and Collaborators

KeraCure

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00330265

Other Study ID Numbers:

NCT 20051320

First Posted:

May 26, 2006

Last Update Posted:

Aug 26, 2008

Last Verified:

Aug 1, 2008

Additional relevant MeSH terms:

Diabetic Foot

Foot Ulcer

Ulcer

Study Results

No Results Posted as of Aug 26, 2008