Clinical trial NCT03793062: Genetic and Epigenetic Basis of Chronic Wounds
Official title: Genetic and Epigenetic Basis of Chronic Wounds
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Wounds
Keywords: genome
epigenome
chronic wounds
genetics
socioeconomic
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-01-04
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 256 clinically diagnosed chronic wound patients will be recruited for this study.

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.

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

Primary outcomes:
measure: Epigenetic and transcriptome changes in debrided tissue from chronic wounds in healing vs non healing phase .
timeFrame: 16 weeks or healing whichever comes first
measure: Wound specific genetic changes using whole genome approaches.
timeFrame: 16 weeks or healing whichever comes first
measure: Identify specific SEEBIN factors.
timeFrame: 16 weeks or healing whichever comes first
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Wound Care Centers
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Chandan K Sen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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