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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:
Information provided by:
KCI USA, Inc.
ClinicalTrials.gov Identifier:
NCT00605189
First received: December 20, 2007
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention
Diabetic Foot Ulcers
 Device: Powered Suction Pump (VAC Freedom)
Device: Powered Suction Pump

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomized, Controlled Trial Examining Cellular Energetics Related To Various Wound Treatment Therapies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by KCI USA, Inc.:

Primary Outcome Measures:
  • cellular energetics [ Time Frame: Day 0, Day 2, Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Normalized Lactate [ Time Frame: Day 0, Day 2, Day 7, Day 30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: July 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605189

Locations
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
Study Director: Gayle M Gordillo, MD Ohio State University
  More Information

No publications provided

Responsible Party: Michele Hilmer / Clinical Trial Manager (CTM), KCI
ClinicalTrials.gov Identifier: NCT00605189     History of Changes
Other Study ID Numbers: VACP2005-009
Study First Received: December 20, 2007
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
 Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on May 22, 2013