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A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies

This study has been terminated.
(Study no longer met business objectives)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00605189
First Posted: January 30, 2008
Last Update Posted: October 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
KCI USA, Inc.
December 20, 2007
January 30, 2008
October 14, 2013
July 2007
November 2010   (Final data collection date for primary outcome measure)
cellular energetics [ Time Frame: Day 0, Day 2, Day 7 ]
Same as current
Complete list of historical versions of study NCT00605189 on ClinicalTrials.gov Archive Site
Normalized Lactate [ Time Frame: Day 0, Day 2, Day 7, Day 30 ]
oxygenation levels [ Time Frame: Day 0, Day 2, Day 7, Day 30 ]
Not Provided
Not Provided
 
A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies
A Randomized, Controlled Trial Examining Cellular Energetics Related To Various Wound Treatment Therapies
A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Diabetic Foot Ulcers
  • Device: Powered Suction Pump (VAC Freedom)
    continuous suction
    Other Name: VAC Freedom
  • Device: Powered Suction Pump
    continuous suction
    Other Name: Gauze-Based Negative Pressure Wound Therapy Device
  • Active Comparator: I
    Intervention: Device: Powered Suction Pump (VAC Freedom)
  • Active Comparator: II
    Intervention: Device: Powered Suction Pump
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
26
November 2010
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type II diabetes
  • Subject has a diabetic foot ulcer 5cm squared or greater
  • Subject's diabetic foot ulcer is chronic

Exclusion Criteria:

  • HgbA1c of 12% or greater
  • Presence of cellulitis
  • Presence of osteomyelitis
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00605189
VACP2005-009
No
Not Provided
Not Provided
KCI USA, Inc.
KCI USA, Inc.
Not Provided
Study Director: Gayle M Gordillo, MD Ohio State University
KCI USA, Inc.
October 2013

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