NCT03793062 · University of Pittsburgh
Genetic and Epigenetic Basis of Chronic Wounds
What this study is about
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 the usual treatment.
View original scientific description
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.
Interventions
OTHER
No Interventions
Not applicable - No Interventions
Primary outcome measures
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).
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
Identify specific SEEBIN factors.
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Pittsburgh, Pennsylvania
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 14, 2026 · Source of record for eligibility and locations