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Genetic and Epigenetic Basis of Chronic Wounds

Genetic and Epigenetic Basis of Chronic Wounds

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03793062
Enrollment
256
Registered
2019-01-04
Start date
2018-12-04
Completion date
2028-12-31
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Wounds

Keywords

genome, epigenome, chronic wounds, genetics, socioeconomic

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.

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. In this prospective pilot study, patients with chronic wounds visiting UPMC (University of Pittsburgh Medical Center) hospitals will be enrolled. Patients enrolled in the study will be followed for 16 weeks (+ or - 2 weeks). Within this time, debrided wound tissue will be collected, when available, as part of their standard of care at the clinics. The study consists of four study visits (Week 0, Week 4, Week 8 and Week 16 or earlier if target would is healed before that time). Study visit 1 consists of obtaining informed consent, medical history, current medications, and baseline demographics including, but not limited to: age, gender, zip code, ethnicity/race, marital status, education level, employment history, household income, number of household member. Digital imaging along with the collection of a saliva and blood sample will be performed during the visit. Participants will be asked to complete fourteen health questionnaires. Study visits two and three consists of digital imaging, along with a medication and adverse event review. Debridement tissue, if available, will be collected, if not collected earlier, during a follow up standard of care as part of wound care visit during the 16-week period. Study visit 4 (Healing Confirmation visit) consists of digital imaging, medication and adverse event review, along with Transepidermal water loss (TEWL) measurements.

Interventions

OTHERNo Interventions

Not applicable - No Interventions

Sponsors

University of Pittsburgh
Lead SponsorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Epigenetic and transcriptome changes in debrided tissue from chronic wounds in healing vs non healing phase .16 weeks or healing whichever comes firstThe 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 firstTo 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 firstTo 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.

Countries

United States

Contacts

CONTACTPiya Das Ghatak, PhD, MS
piya.dasghatak@pitt.edu412-648-8297
CONTACTSashwati Roy, PhD
sar453@pitt.edu412-648-8297
PRINCIPAL_INVESTIGATORChandan K Sen, PhD

University of Pittsburgh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026