Genetic and Epigenetic Basis of Chronic Wounds

NCT ID: NCT03793062

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 256 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-04
• Study Completion Date: 2028-12-31

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.

Conditions

Chronic Wounds

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

No Interventions

Not applicable - No Interventions

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Chandan Sen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chandan K Sen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Wound Care Centers

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kiyan Shadmani, MPH

Role: CONTACT

kiyanshadmani@pitt.edu

234-380-9436

Sashwati Roy, PhD

Role: CONTACT

sar453@pitt.edu

412-648-8297

Facility Contacts

Kiyan Shadmani, MPH

Role: primary

kiyanshadmani@pitt.edu

234-380-9436

Urmila Gnyawali, CCRP

Role: backup

usg2@pitt.edu

614-371-2028

References

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Reference Type: BACKGROUND

PMID: 10471461 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 19903300 (View on PubMed)

Crovetti G, Martinelli G, Issi M, Barone M, Guizzardi M, Campanati B, Moroni M, Carabelli A. Platelet gel for healing cutaneous chronic wounds. Transfus Apher Sci. 2004 Apr;30(2):145-51. doi: 10.1016/j.transci.2004.01.004.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

R01DK135447

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY23080025

Identifier Type: -

Identifier Source: org_study_id