Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2008-09-01
2030-12-31
Brief Summary
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Detailed Description
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1. To study biology of wound derived inflammatory cells and fluid from diabetic versus non diabetic wounds.
2. To characterize mechanisms that are responsible for dysregulated wound inflammatory cell function in individuals with diabetes.
3. To characterize differences in the biology of normal peripheral blood derived cells versus wound derived cells.
The long-term goal of this study is to determine the molecular mechanisms underlying impaired wound healing in diabetics.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Diabetic wound study
Patients with diabetes or no diabetes
Blood draw
Blood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care).
Interventions
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Blood draw
Blood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care).
Eligibility Criteria
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Inclusion Criteria
* Chronic Wound (present \>4 weeks)
* Diabetic \& Non-diabetic
* Adult surgical wounds
Exclusion Criteria
* Pregnant women
* Therapeutically immunocompromised
* Individuals defined in 45 CFR 46 Subparts B,C, and D, nor from any other population considered vulnerable 2.9
21 Years
80 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Sashwati Roy
Professor
Principal Investigators
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Sashwati Roy, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Comprehensive Wound Care Centers
Indianapolis, Indiana, United States
Comprehensive Wound Care Centers
Columbus, Ohio, United States
University of Pittsburgh - McKeesport
Pittsburgh, Pennsylvania, United States
University of Pittsburgh - Mercy
Pittsburgh, Pennsylvania, United States
University of Pittsburgh - Passavant
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Mousley M. Diabetes and its effect on wound healing and patient care. Nurs Times. 2003 Oct 21-27;99(42):70, 73-4.
Stadelmann WK, Digenis AG, Tobin GR. Impediments to wound healing. Am J Surg. 1998 Aug;176(2A Suppl):39S-47S. doi: 10.1016/s0002-9610(98)00184-6.
Meehan M, O'Hara L, Morrison YM. Report on the prevalence of skin ulcers in a home health agency population. Adv Wound Care. 1999 Nov-Dec;12(9):459-67.
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2007 Jan;30 Suppl 1:S42-7. doi: 10.2337/dc07-S042. No abstract available.
American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41. doi: 10.2337/dc07-S004. No abstract available.
Related Links
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IU Center for Regenerative Medicine and Cell Based Therapies
Other Identifiers
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STUDY23070132
Identifier Type: -
Identifier Source: org_study_id
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