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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.
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 procedures will take place once your appointment has been completed:
During the 14-week follow-up visit, research staff will review the participant's medical chart to determine the final status of the wound. If the participant does not return to the CWC at 14 weeks, the last CWC visit will be documented as the wound check follow-up. This does not require the participant to return for an extra study visit. This information will only be collected from their medical chart if available:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic patients infected ulcers | Diabetic patients with HbA1c<9 with who have wound 4weeks or longer with infection with following interventions:
|
| |
| Diabetic patients non infected Ulcers | Diabetic patients with HbA1c<9 who have wound 4 weeks or longer without infection with following interventions:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finger prick test for HbA1c measurement | Diagnostic Test | HbA1c measurement with finger prick method |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Inadequate arterial supply, as evidenced by any of the following (for wounds below the knee):
Women who are pregnant
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Sashwati Roy, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States | ||
| Davis Heart and Lung Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7769212 | Background | Breen JD, Karchmer AW. Staphylococcus aureus infections in diabetic patients. Infect Dis Clin North Am. 1995 Mar;9(1):11-24. | |
| 17118226 | Background | 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. |
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Blood, Wound Vac Sponge, Wound Tissue biopsy
| Punch Biopsy | Procedure | 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). |
|
| Vac Sponge Collection | Other | NPWT sponge which is discarded as biological waste, will be collected for wound macrophage isolation |
|
| Ankle Brachial Index | Other | Blood pressure test |
|
| 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 |
| 18086294 | Background | 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. |
| 22879997 | Background | 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. |
| 23365077 | Background | 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. |
| 21561305 | Background | 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. |
| 24527355 | Background | 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. |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001424 | Bacterial Infections |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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