Back to resultsA Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies
Primary Purpose
Diabetic Foot Ulcers
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Powered Suction Pump (VAC Freedom)
Powered Suction Pump
MWT
Sponsored by
About this trial
This is an interventional basic science trial for Diabetic Foot Ulcers
Eligibility 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
Sites / Locations
- The Ohio State University Medical Center
- University of Texas Health Science Center San Antonio
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
VAC NPWT
Gauze-Based NPWT
Moist Wound Therapy
Arm Description
Outcomes
Primary Outcome Measures
Compare Energy Charge Between Wound Treatment Therapies
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00605189
Brief Title
A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies
Official Title
A Randomized, Controlled Trial Examining Cellular Energetics Related To Various Wound Treatment Therapies
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Study no longer met business objectives
Study Start Date
July 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VAC NPWT
Arm Type
Active Comparator
Arm Title
Gauze-Based NPWT
Arm Type
Active Comparator
Arm Title
Moist Wound Therapy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Powered Suction Pump (VAC Freedom)
Other Intervention Name(s)
VAC Freedom
Intervention Description
continuous foam based negative pressure wound therapy
Intervention Type
Device
Intervention Name(s)
Powered Suction Pump
Other Intervention Name(s)
Gauze-Based Negative Pressure Wound Therapy Device
Intervention Description
continuous gauze based negative pressure wound therapy
Intervention Type
Device
Intervention Name(s)
MWT
Intervention Description
moist wound therapy
Primary Outcome Measure Information:
Title
Compare Energy Charge Between Wound Treatment Therapies
Description
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
Time Frame
Day 0, Day 2, Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gayle M Gordillo, MD
Organizational Affiliation
Ohio State University
Official's Role
Study Director
Facility Information:
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Texas Health Science Center San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies
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