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

Primary Purpose

Foot Ulcer, Diabetes

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
KC-002
Conventional Wound Therapy
Sponsored by
KeraCure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute for Advanced Wound Care at Baptist Medical Center SouthRecruiting
  • HOPE Research InstituteRecruiting
  • Southern Arizona VA Health Care SystemRecruiting
  • Roy Kroeker, DPMRecruiting
  • Felix Sigal, DPMRecruiting
  • Bay Area Foot CareRecruiting
  • North American Center for Limb PreservationRecruiting
  • Georgetown University / Wound Healing CenterRecruiting
  • Doctor's Research NetworkRecruiting
  • Medical AssociatesRecruiting
  • Sinai Hospital of BaltimoreRecruiting
  • Preston Family BuildingRecruiting
  • Foot Healthcare Associates, PCRecruiting
  • St. Vincent Health Center Wound ClinicRecruiting
  • Pivotal Clinical ResearchRecruiting
  • Warren General Hospital Wound ClinicRecruiting
  • Martin Foot and AnkleRecruiting
  • San Antonio Podiatry Associates, PCRecruiting
  • Pharmaceutical Research OrganizationRecruiting
  • Dixie Regional Medical Center's Wound ClinicRecruiting
  • Central Washington Podiatry ServiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

KC-002

Conventional Wound Therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 24, 2006
Last Updated
August 25, 2008
Sponsor
KeraCure
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1. Study Identification

Unique Protocol Identification Number
NCT00330265
Brief Title
Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
KeraCure

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
KC-002
Arm Title
2
Arm Type
Other
Arm Description
Conventional Wound Therapy
Intervention Type
Device
Intervention Name(s)
KC-002
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Wound Therapy
Intervention Description
Normal Saline Dressings
Primary Outcome Measure Information:
Title
Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
M Meek
Phone
866-537-2287
Email
clinicaltrial@keracure.com
Facility Information:
Facility Name
Institute for Advanced Wound Care at Baptist Medical Center South
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
334-286-3444
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
602-274-4100
Facility Name
Southern Arizona VA Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
520-792-1450
Facility Name
Roy Kroeker, DPM
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
559-436-8162
Facility Name
Felix Sigal, DPM
City
Los Angeles
State/Province
California
ZIP/Postal Code
90010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
888-860-4325
Facility Name
Bay Area Foot Care
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
415-292-0638
Facility Name
North American Center for Limb Preservation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06515
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
203-397-0624
Facility Name
Georgetown University / Wound Healing Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
202-444-1784
Facility Name
Doctor's Research Network
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-662-1444
Facility Name
Medical Associates
City
Clinton
State/Province
Iowa
ZIP/Postal Code
52732
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
563-519-1871
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
410-601-5106
Facility Name
Preston Family Building
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
617-414-6840
Facility Name
Foot Healthcare Associates, PC
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
734-542-9305
Facility Name
St. Vincent Health Center Wound Clinic
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16444
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
814-452-7878
Facility Name
Pivotal Clinical Research
City
Souderton
State/Province
Pennsylvania
ZIP/Postal Code
18964
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
215-723-7121
Facility Name
Warren General Hospital Wound Clinic
City
Warren
State/Province
Pennsylvania
ZIP/Postal Code
16365
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
814-723-3300
Ext
2752
Facility Name
Martin Foot and Ankle
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
717-718-0216
Facility Name
San Antonio Podiatry Associates, PC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
210-949-0807
Facility Name
Pharmaceutical Research Organization
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
801-294-9911
Facility Name
Dixie Regional Medical Center's Wound Clinic
City
St. George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
435-688-5281
Facility Name
Central Washington Podiatry Service
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
509-248-2900

12. IPD Sharing Statement

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

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