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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by KeraCure.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
KeraCure
ClinicalTrials.gov Identifier:
NCT00330265
First received: May 24, 2006
Last updated: August 25, 2008
Last verified: August 2008

May 24, 2006
August 25, 2008
January 2006
March 2009   (final data collection date for primary outcome measure)
Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00330265 on ClinicalTrials.gov Archive Site
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Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Foot Ulcer
  • Diabetes
  • 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
  • Experimental: 1
    KC-002
    Intervention: Device: KC-002
  • 2
    Conventional Wound Therapy
    Intervention: Other: Conventional Wound Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
September 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: M Meek 866-537-2287 clinicaltrial@keracure.com
United States
 
NCT00330265
NCT 20051320
Yes
KeraCure
KeraCure
Not Provided
Not Provided
KeraCure
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP