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. Identifier: NCT00605189
Recruitment Status : Terminated (Study no longer met business objectives)
First Posted : January 30, 2008
Last Update Posted : October 14, 2013
Information provided by (Responsible Party):

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: I Device: Powered Suction Pump (VAC Freedom)
continuous suction
Other Name: VAC Freedom

Active Comparator: II Device: Powered Suction Pump
continuous suction
Other Name: Gauze-Based Negative Pressure Wound Therapy Device

Primary Outcome Measures :
  1. cellular energetics [ Time Frame: Day 0, Day 2, Day 7 ]

Secondary Outcome Measures :
  1. Normalized Lactate [ Time Frame: Day 0, Day 2, Day 7, Day 30 ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00605189

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
Study Director: Gayle M Gordillo, MD Ohio State University

Responsible Party: KCI USA, Inc. Identifier: NCT00605189     History of Changes
Other Study ID Numbers: VACP2005-009
First Posted: January 30, 2008    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
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