NCT03793062 Genetic and Epigenetic Basis of Chronic Wounds
| NCT ID | NCT03793062 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Chronic Wounds |
| Study Type | OBSERVATIONAL |
| Enrollment | 256 participants |
| Start Date | 2018-12-04 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 256 participants in total. It began in 2018-12-04 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Willing to comply with protocol instructions, including all study visits and study activities. * Chronic wounds (\> than four weeks since onset) * Clinically diagnosed diabetic or non-diabetic ulcer. * For patients with multiple wounds, the largest wound will be used for the study. 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 (self-declared) or lactating * Subjects with marked immunodeficiency (HIV/AIDS or immune-suppressive medications) * Prisoners
Contact & Investigator
Chandan K Sen, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT03793062 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Chronic Wounds. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03793062 currently recruiting?
Yes, NCT03793062 is actively recruiting participants. Contact the research team at piya.dasghatak@pitt.edu for enrollment information.
Where is the NCT03793062 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT03793062 clinical trial?
NCT03793062 is sponsored by University of Pittsburgh. The principal investigator is Chandan K Sen, PhD at University of Pittsburgh. The trial plans to enroll 256 participants.