Genetic and Epigenetic Basis of Chronic Wounds
ConditionChronic Wounds
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Pittsburgh
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
256 clinically diagnosed chronic wound patients will be recruited for this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Interventions
Other interventionNot applicable - No Interventions
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Epigenetic and transcriptome changes in debrided tissue from chronic wounds in healing vs non healing phase .
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).
Time frame
16 weeks or healing whichever comes first2
Wound specific genetic changes using whole genome approaches.
To characterize wound specific genetic changes (e.g., mutations) using whole genome approaches. Genome from blood cells will be used as reference
Time frame
16 weeks or healing whichever comes first3
Identify specific SEEBIN factors.
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.
Time frame
16 weeks or healing whichever comes firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov