Mechanisms Underlying Impaired Diabetic Wound Healing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mechanisms Underlying Impaired Diabetic Wound Healing

Conditions
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Non-healing Wounds, Diabetes

Intervention / Treatment
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* Other: Blood draw


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine molecular mechanisms underlying impaired wound healing in diabetes |  | Same day as collection for each subject, one year for completion of overall results | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize differences in biology between normal peripheral blood derived cells and wound derived cells. |  | 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 |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound healing, diabetes, inflammatory cell, monocyte, leukocyte, macrophage