Study Stopped
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Biofilm Modified Macrophage Phenotype and Function in Diabetic Wound Healing
1 other identifier
observational
31
1 country
5
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 grouping of bacteria is called a biofilm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2020
5 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
First Submitted
Initial submission to the registry
June 12, 2017
CompletedFirst Posted
Study publicly available on registry
September 5, 2017
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2021
CompletedApril 25, 2024
April 1, 2024
1.6 years
June 12, 2017
April 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Biofilm infection
Biofilm Infection using SEM and RT PCR analysis
14 Weeks
macrophage phenotyping
Wound macrophage phenotypes using flowcytometry, RTPCR and RNA Seq
14 Weeks
Study Arms (2)
Diabetic patients infected ulcers
Diabetic patients with HbA1c\<9 with who have wound 4weeks or longer with infection with following interventions: 1. Finger prick test for HbA1c measurement 2. Punch biopsy 3. VAC sponge collection 4. Ankle brachial index
Diabetic patients non infected Ulcers
Diabetic patients with HbA1c\<9 who have wound 4 weeks or longer without infection with following interventions: 1. Finger prick test for HbA1c measurement 2. Punch biopsy 3. VAC sponge collection 4. Ankle brachial index
Interventions
HbA1c measurement with finger prick method
Wound site will be anaesthetized, by punch biopsy tissue will be collected, wound site will be monitored for bleeding(if bleeding Cautery will be used to stop bleeding).
NPWT sponge which is discarded as biological waste, will be collected for wound macrophage isolation
Blood pressure test
Eligibility Criteria
Twenty-eight diabetic subjects with chronic foot ulcer(s) that are receiving Negative Wound Pressure Therapy (NPWT) will be enrolled. Eighteen subjects will be infected and 10 subjects will be non-infected serving as the control for the study. The inclusion and exclusion criteria were carefully selected to enroll diabetic patients who have wound tissue oxygenation adequate to support wound healing.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Davis Heart and Lung Institute
Columbus, Ohio, 42310, United States
The Ohio State University Hospital East
Columbus, Ohio, 43203, United States
Comprehensive Wound Care Centers, The Ohio State University Hospital
Columbus, Ohio, 43210, United States
Martha Morehouse Medical Plaza
Columbus, Ohio, 43221, United States
Related Publications (7)
Breen JD, Karchmer AW. Staphylococcus aureus infections in diabetic patients. Infect Dis Clin North Am. 1995 Mar;9(1):11-24.
PMID: 7769212BACKGROUNDDavis SC, Martinez L, Kirsner R. The diabetic foot: the importance of biofilms and wound bed preparation. Curr Diab Rep. 2006 Dec;6(6):439-45. doi: 10.1007/s11892-006-0076-x.
PMID: 17118226BACKGROUNDJames GA, Swogger E, Wolcott R, Pulcini Ed, Secor P, Sestrich J, Costerton JW, Stewart PS. Biofilms in chronic wounds. Wound Repair Regen. 2008 Jan-Feb;16(1):37-44. doi: 10.1111/j.1524-475X.2007.00321.x. Epub 2007 Dec 13.
PMID: 18086294BACKGROUNDHanke ML, Angle A, Kielian T. MyD88-dependent signaling influences fibrosis and alternative macrophage activation during Staphylococcus aureus biofilm infection. PLoS One. 2012;7(8):e42476. doi: 10.1371/journal.pone.0042476. Epub 2012 Aug 3.
PMID: 22879997BACKGROUNDHanke ML, Heim CE, Angle A, Sanderson SD, Kielian T. Targeting macrophage activation for the prevention and treatment of Staphylococcus aureus biofilm infections. J Immunol. 2013 Mar 1;190(5):2159-68. doi: 10.4049/jimmunol.1202348. Epub 2013 Jan 30.
PMID: 23365077BACKGROUNDNeut D, Tijdens-Creusen EJ, Bulstra SK, van der Mei HC, Busscher HJ. Biofilms in chronic diabetic foot ulcers--a study of 2 cases. Acta Orthop. 2011 Jun;82(3):383-5. doi: 10.3109/17453674.2011.581265. Epub 2011 May 11. No abstract available.
PMID: 21561305BACKGROUNDZhao G, Usui ML, Lippman SI, James GA, Stewart PS, Fleckman P, Olerud JE. Biofilms and Inflammation in Chronic Wounds. Adv Wound Care (New Rochelle). 2013 Sep;2(7):389-399. doi: 10.1089/wound.2012.0381.
PMID: 24527355BACKGROUND
Biospecimen
Blood, Wound Vac Sponge, Wound Tissue biopsy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sashwati Roy, PhD
Indiana University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 12, 2017
First Posted
September 5, 2017
Study Start
February 1, 2020
Primary Completion
September 13, 2021
Study Completion
September 13, 2021
Last Updated
April 25, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share