A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies
October 14, 2024 updated by: KCI USA, Inc
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University Medical Center
-
-
Texas
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center San Antonio
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: VAC NPWT
|
continuous foam based negative pressure wound therapy
Other Names:
|
|
Active Comparator: Gauze-Based NPWT
|
continuous gauze based negative pressure wound therapy
Other Names:
|
|
Active Comparator: Moist Wound Therapy
|
moist wound therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
Day 0, Day 2, Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gayle M Gordillo, MD, Ohio State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
January 29, 2008
First Posted (Estimated)
January 30, 2008
Study Record Updates
Last Update Posted (Actual)
October 16, 2024
Last Update Submitted That Met QC Criteria
October 14, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VACP2005-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.