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Observational Study of Genetic and Epigenetic Factors in Chronic Wounds

This study is looking into why some chronic wounds (wounds that haven't healed in over four weeks) don't heal properly. Researchers believe there might be specific genetic (related to your genes) and epigenetic (how your genes are expressed) differences in these wounds. You could join if you are an adult (18-100 years old) with a chronic wound, whether or not you have diabetes. The study aims to understand these genetic and epigenetic changes by comparing tissue samples from your wound with blood samples. Success for this study means identifying specific genetic and epigenetic patterns that are linked to wounds that heal versus those that don't, which could lead to better treatments in the future. The current status of this study is unclear.

Study design
This is an observational study, meaning no new treatments are given. It plans to enroll 256 participants.
What's involved
You would need to agree to follow study instructions and attend all study visits. Tissue from your wound will be collected during routine care, and blood samples will also be taken. You would be followed for 16 weeks, or until your wound heals, whichever comes first.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 16 weeks, or until their wound heals, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03793062

Genetic and Epigenetic Basis of Chronic Wounds

Recruiting
Not specifiedAges 18+Observational
University of Pittsburgh
~256 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:No Interventions

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Epigenetic and transcriptome changes in debrided tissue from chronic wounds in healing vs non healing phase .
Measured over 16 weeks or healing whichever comes first
+2 more outcomes measured

Conditions

Chronic Wounds

Explore related trials

Wound

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Chandan K Sen, PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Piya Das Ghatak, PhD, MS
[email protected]
412-648-8297
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Epigenetic and transcriptome changes in debrided tissue from chronic wounds in healing vs non healing phase .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).

  • Wound specific genetic changes using whole genome approaches.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

  • Identify specific SEEBIN factors.16 weeks or healing whichever comes first

    To Determine the significance of socio-economic, environmental, behavioral, immunological and nutritional (SEEBIN) factors in modifying chronic wound (CW) tissue genomics in a way that affects healing trajectory.