Mechanisms Underlying Impaired Diabetic Wound Healing (WoundVac)

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ClinicalTrials.gov Identifier: NCT00777712

Recruitment Status : Recruiting

First Posted : October 22, 2008

Last Update Posted : May 11, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Sashwati Roy, Indiana University

Study Description

Brief Summary:

The overall aim of this research is to utilize wound derived inflammatory cells from diabetic versus non diabetic human chronic wounds to understand mechanisms that are responsible for disregulated inflammation in individuals with diabetes. Biology of normal (peripheral blood derived cells) versus wound derived cells will also be studied.

Condition or disease	Intervention/treatment
Non-healing Wounds Diabetes	Other: Blood draw

Detailed Description:

Specific aims:

To study biology of wound derived inflammatory cells and fluid from diabetic versus non diabetic wounds.
To characterize mechanisms that are responsible for dysregulated wound inflammatory cell function in individuals with diabetes.
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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	300 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Mechanisms Underlying Impaired Diabetic Wound Healing
Study Start Date :	September 2008
Estimated Primary Completion Date :	December 2020
Estimated Study Completion Date :	December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Wounds and Injuries

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Diabetics (HbA1c level >8%) with infection Poorly controlled diabetes in patients with HbA1c level >8% who have wound (s) 4 weeks or longer with infection. N=50	Other: Blood draw Blood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care).
Normoglycemic- with infection Non-Diabetic patients with wound(s) 4 weeks or longer with infection. N=50	Other: Blood draw Blood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care).
Diabetics (HbA1c level >8%) without infection Poorly controlled diabetes in patients with HbA1c level >8% who have wound (s) 4 weeks or longer without infection. N=50	Other: Blood draw Blood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care).
Normoglycemic- without infection Non-Diabetic patients with wound(s)4 weeks or longer without infection. N=50	Other: Blood draw Blood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care).
Diabetics (HbA1c level<8%) with infection Patients with controlled diabetes with HbA1c level<8% who have wound (s) 4 weeks or longer and also with infection. N=50	Other: Blood draw Blood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care).
Diabetics (HbA1c level <8%) without infection Patients with controlled diabetes with HbA1c level <8% who have wound (s) 4 weeks or longer and also without infection. N=50	Other: Blood draw Blood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care).

Outcome Measures

Primary Outcome Measures :

Determine molecular mechanisms underlying impaired wound healing in diabetes [ Time Frame: Same day as collection for each subject, one year for completion of overall results ]

Secondary Outcome Measures :

Characterize differences in biology between normal peripheral blood derived cells and wound derived cells. [ Time Frame: One day for each experiment (begins after each collection), one year for characterization ]
Characterize mechanisms responsible for dysregulated wound inflammatory cell function in patients with diabetes [ Time Frame: one year ]

Biospecimen Retention: Samples With DNA

Blood, Wound Vac Sponge.

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients will be recruited at the Comprehensive Wound Care Centers: Indiana University/ Indiana University Health Hospitals

Criteria

Inclusion Criteria:

Ages 21-80
Chronic Wound (present >4 weeks)
Diabetic & Non-diabetic
Adult surgical wounds

Exclusion Criteria:

Inability to consent
Pregnant women
Therapeutically immunocompromised
Individuals defined in 45 CFR 46 Subparts B,C, and D, nor from any other population considered vulnerable 2.9

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777712

Contacts

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Contact: Jennifer Mohnacky, RDN	317-278-2720	jmohnack@iu.edu
Contact: Tammy Garrett, RN	317-278-2016	tjgarret@iupui.edu

Locations

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United States, Indiana
Comprehensive Wound Care Centers	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jennifer Mohnacky, RDN 317-278-2720 jmohnack@iu.edu
Principal Investigator: Sashwati Roy, Ph.D
Sub-Investigator: Gayle Gordillo, MD

Sponsors and Collaborators

Sashwati Roy

Investigators

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Principal Investigator:	Sashwati Roy, Ph.D.	Indiana University

More Information

Additional Information:

OSU Comprehensive Wound Center This link exits the ClinicalTrials.gov site

OSU Center for Regenerative Medicine and Cell Based Therapies This link exits the ClinicalTrials.gov site

Publications:

Mousley M. Diabetes and its effect on wound healing and patient care. Nurs Times. 2003 Oct 21-27;99(42):70, 73-4. Review.

Stadelmann WK, Digenis AG, Tobin GR. Impediments to wound healing. Am J Surg. 1998 Aug;176(2A Suppl):39S-47S. Review.

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.

American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41.

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Responsible Party:	Sashwati Roy, Professor, Indiana University
ClinicalTrials.gov Identifier:	NCT00777712
Other Study ID Numbers:	1901962183
First Posted:	October 22, 2008 Key Record Dates
Last Update Posted:	May 11, 2020
Last Verified:	May 2020

Keywords provided by Sashwati Roy, Indiana University:


Wound healing diabetes inflammatory cell	monocyte leukocyte macrophage

Additional relevant MeSH terms:

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Wounds and Injuries

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