Genetic & Epigenetic Basis of Chronic Wounds

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03793062
Study type	Observational
Source	Indiana University
Contact
Status	Active, not recruiting
Phase
Start date	December 4, 2018
Completion date	December 1, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Genetic and Epigenetic Basis of Chronic Wounds

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms