NCT03271580|Terminated
Study Stopped
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Sponsor study identifier
observational
31
1 country
5
Study Start
February 1, 2020
Actual (reported)Primary Completion
September 13, 2021
Actual (reported)Study Completion
September 13, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 13, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 12, 2017
Actual (reported)September 5, 2017
Actual (reported)February 1, 2020
Actual (reported)September 13, 2021
Actual (reported)September 13, 2021
Actual (reported)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
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 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
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).
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.
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
Breen JD, Karchmer AW. Staphylococcus aureus infections in diabetic patients. Infect Dis Clin North Am. 1995 Mar;9(1):11-24.
Davis 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.
James 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.
Blood, Wound Vac Sponge, Wound Tissue biopsy
Sashwati Roy, PhD
Indiana University
31 participants (actual enrollment reported by the registry).
First Submitted
June 12, 2017
First Posted
September 5, 2017
Study Start
February 1, 2020
Actual (reported)Biofilm Infection in Adults and Children Burn Injury
NPWT sponge which is discarded as biological waste, will be collected for wound macrophage isolation
Blood pressure test
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Hanke 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.
Hanke 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.
Neut 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.
Zhao 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.
Primary Completion
September 13, 2021
Actual (reported)Study Completion
September 13, 2021
Actual (reported)Last Updated
April 25, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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