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Genetic and Epigenetic Basis of Chronic Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03793062
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : April 1, 2019
Information provided by (Responsible Party):
Chandan Sen, Indiana University

Brief 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.

Condition or disease Intervention/treatment
Chronic Wounds Other: no interventions

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic and Epigenetic Basis of Chronic Wounds
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: no interventions
    Not applicable- no interventions

Primary Outcome Measures :
  1. Epigenetic and transcriptome changes in debrided tissue from chronic wounds in healing vs non healing phase . [ Time Frame: 16 weeks or healing whichever comes first ]
    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).

  2. Wound specific genetic changes using whole genome approaches. [ Time Frame: 16 weeks or healing whichever comes first ]
    To characterize wound specific genetic changes (e.g., mutations) using whole genome approaches. Genome from blood cells will be used as reference

Biospecimen Retention:   Samples With DNA
wound debrided tissue and blood samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
50 clinically diagnosed chronic wound patients will be recruited for this study.

Inclusion Criteria:

  • Age ≥ 18 years
  • Willing to comply with protocol instructions, including all study visits and study activities.
  • Chronic wounds

Exclusion Criteria:

  • Pregnant females
  • Subjects with marked immunodeficiency (HIV/AIDS)
  • Prisoners

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 identifier (NCT number): NCT03793062

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Contact: Jennifer Mohnacky 317-278-2715
Contact: Sashwati Roy, PhD 3172782706

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United States, Indiana
IU Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Mohnacky Jennifer, RD         
Sponsors and Collaborators
Chandan Sen
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Principal Investigator: Chandan K Sen, PhD Indiana University


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Responsible Party: Chandan Sen, Professor, Indiana University Identifier: NCT03793062     History of Changes
Other Study ID Numbers: 1809585623
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chandan Sen, Indiana University:
chronic wounds
Additional relevant MeSH terms:
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Wounds and Injuries