Study Stopped
Study no longer met business objectives
A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies
A Randomized, Controlled Trial Examining Cellular Energetics Related To Various Wound Treatment Therapies
1 other identifier
interventional
50
1 country
2
Brief Summary
A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2007
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
January 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
December 12, 2018
CompletedOctober 16, 2024
October 1, 2024
3.3 years
December 20, 2007
December 29, 2017
October 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Day 0, Day 2, Day 7
Study Arms (3)
VAC NPWT
ACTIVE COMPARATORGauze-Based NPWT
ACTIVE COMPARATORMoist Wound Therapy
ACTIVE COMPARATORInterventions
continuous foam based negative pressure wound therapy
continuous gauze based negative pressure wound therapy
Eligibility Criteria
You may qualify if:
- Type II diabetes
- Subject has a diabetic foot ulcer 5cm squared or greater
- Subject's diabetic foot ulcer is chronic
You may not qualify if:
- HgbA1c of 12% or greater
- Presence of cellulitis
- Presence of osteomyelitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KCI USA, Inclead
Study Sites (2)
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Global Clinical Development
- Organization
- KCI, an Acelity Company
Study Officials
- STUDY DIRECTOR
Gayle M Gordillo, MD
Ohio State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
January 30, 2008
Study Start
July 1, 2007
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
October 16, 2024
Results First Posted
December 12, 2018
Record last verified: 2024-10