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A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies

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.
 
ClinicalTrials.gov Identifier: NCT00605189
Recruitment Status : Terminated (Study no longer met business objectives)
First Posted : January 30, 2008
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.

Study Description
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Brief Summary:
A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Device: Powered Suction Pump (VAC Freedom) Device: Powered Suction Pump Device: MWT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized, Controlled Trial Examining Cellular Energetics Related To Various Wound Treatment Therapies
Study Start Date : July 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: VAC NPWT Device: Powered Suction Pump (VAC Freedom)
continuous foam based negative pressure wound therapy
Other Name: VAC Freedom
Active Comparator: Gauze-Based NPWT Device: Powered Suction Pump
continuous gauze based negative pressure wound therapy
Other Name: Gauze-Based Negative Pressure Wound Therapy Device
Active Comparator: Moist Wound Therapy Device: MWT
moist wound therapy


Outcome Measures
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Primary Outcome Measures :
  1. Compare Energy Charge Between Wound Treatment Therapies [ Time Frame: Day 0, Day 2, Day 7 ]

    Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit.

    Energy Charge is calculated as follows:

    Energy Charge = (ATP + (0.5 * ADP)) / (ATP + ADP + AMP)

    Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605189


Locations
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United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Texas
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
KCI USA, Inc.
Investigators
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Study Director: Gayle M Gordillo, MD Ohio State University
More Information
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Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT00605189    
Other Study ID Numbers: VACP2005-009
First Posted: January 30, 2008    Key Record Dates
Results First Posted: December 12, 2018
Last Update Posted: December 12, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
 Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases