Status:
TERMINATED
Biofilm Modified Macrophage Phenotype and Function in Diabetic Wound Healing
Lead Sponsor:
Indiana University
Conditions:
Wound
Bacterial Infections
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to learn more about biofilm and to see how it affects diabetic wounds. A biofilm can occur if a chronic infection causes bacteria to grow in a slime enclosed group. This g...
Detailed Description
There is one study visit with a 14-week follow-up that will take place during the participants standard of care visit at the Indiana University Health Comprehensive Wound Center (CWC). The following p...
Eligibility Criteria
Inclusion
- Age 18 and above years old
- Willing and able to provide informed consent
- Willing and able to comply with protocol instructions, including biopsies and study visits
- Diabetics with an open wound
- Receiving Negative Wound Pressure Therapy (NPWT)
Exclusion
- Inadequate arterial supply, as evidenced by any of the following (for wounds below the knee):
- TcOM \< 30mmHg
- ABI \< 0.7
- TBI \< 0.6
- Women who are pregnant
Key Trial Info
Start Date :
February 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 13 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03271580
Start Date
February 1 2020
End Date
September 13 2021
Last Update
April 25 2024
Active Locations (5)
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1
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
2
Davis Heart and Lung Institute
Columbus, Ohio, United States, 42310
3
The Ohio State University Hospital East
Columbus, Ohio, United States, 43203
4
Comprehensive Wound Care Centers, The Ohio State University Hospital
Columbus, Ohio, United States, 43210