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

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). |
- 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 ]
- 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

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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 |
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

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
Contact: Jennifer Mohnacky, RDN | 317-278-2720 | jmohnack@iu.edu | |
Contact: Tammy Garrett, RN | 317-278-2016 | tjgarret@iupui.edu |
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 |
Principal Investigator: | Sashwati Roy, Ph.D. | Indiana University |
Publications:
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 |
Wound healing diabetes inflammatory cell |
monocyte leukocyte macrophage |
Wounds and Injuries |