Biofilm Modified Macrophage Phenotype and Function in Diabetic Wound Healing

Stopped early

Conditions studied: Wound, Bacterial Infections, Diabetes Mellitus, Infected Ulcer of Skin

In brief

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 grouping of bacteria is called a biofilm.

Key facts

Study ID

NCT03271580

Run by

Indiana University

People needed

31

Starts

2020-02-01

Expected to finish

2021-09-13

Last updated by the study team

2024-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• IU Health Methodist Hospital — Indianapolis, Indiana, United States
• Davis Heart and Lung Institute — Columbus, Ohio, United States
• The Ohio State University Hospital East — Columbus, Ohio, United States
• Comprehensive Wound Care Centers, The Ohio State University Hospital — Columbus, Ohio, United States
• Martha Morehouse Medical Plaza — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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