Genetic and Epigenetic Basis of Chronic Wounds

Study Overview
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Brief Summary
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This pilot study is designed for chronic wounds that fail to heal in a timely manner carry specific genetic signatures. These genetic signatures will be studied using debrided wound tissue that is removed by the wound care provider as part of standard of care. The reference genomic signature will be evaluated by obtaining blood samples and will be compared with wound debrided tissue genomic signature to understand wound specific genomic changes.

Detailed Description
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Chronic wounds affect a large fraction of the world population and poses major threat to the public health and economy of the United States affecting 6.5 million patients. It has been estimated that approximately 2% of the population residing in developed countries, will experience at least one chronic wound during their lifetime. Current treatment options for chronic wounds are insufficient due to lack of individual specific genetic information. To improve therapy, an increase in the investigator's understanding of the genetic predisposition of individuals which result in impaired wound healing response is warranted. Information about these individual specific genetic and epigenetic regulations can altogether yield subset of repair genes which can serve as master regulators of wound healing. The effect of specific genetic information is also modified a lot by environmental epigenetic factors. Epigenetic changes have been shown to control the wound healing outcomes. In this prospective pilot study, patients with chronic wounds visiting Indiana University/IU Health clinics/ hospitals will be enrolled. Patients enrolled in the study will be followed for 16 weeks. Within this time, debrided wound tissue will be collected, when available, as part of their standard of care at the clinics. The study consists of two study visits (week 1 and week 16 or earlier if target would is healed before that time). Study visit 1 consists of obtaining informed consent, medical history, current medications, and baseline demographics including, but not limited to: age, gender, zip code, ethnicity/race, marital status, education level, employment history, household income, number of household member. Digital imaging along with the collection of a saliva and blood sample will be performed during the visit. Participants will be asked to complete eight health questionnaires. Study visit two consists of digital imaging, along with a medication and adverse event review.

Official Title
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Genetic and Epigenetic Basis of Chronic Wounds

Conditions
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Chronic Wounds

Intervention / Treatment
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* Other: No Interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Willing to comply with protocol instructions, including all study visits and study activities. Chronic wounds or acute wounds scheduled for debridement in >30 days since onset Exclusion Criteria: Individuals who are deemed unable to understand the procedures, risks and benefits of the study,(i.e. unable to provide informed consent) Pregnant females Subjects with marked immunodeficiency (HIV/AIDS) Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Other: No Interventions|Not applicable - No Interventions|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epigenetic and transcriptome changes in debrided tissue from chronic wounds in healing vs non healing phase . | The wound area (digital planimetry at d0/ 16 week) will classify wounds as heal-high (final 16 week size <40% of initial visit, d0) or heal-low (>60% of initial d0). | 16 weeks or healing whichever comes first | 
| Wound specific genetic changes using whole genome approaches. | To characterize wound specific genetic changes (e.g., mutations) using whole genome approaches. Genome from blood cells will be used as reference | 16 weeks or healing whichever comes first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genome, epigenome, chronic wounds, genetics