Recruiting

Chronic Wounds

Sponsor:

University of Pittsburgh

Code:

NCT03793062

Conditions

Chronic Wounds

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

No Interventions

Study Details

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.

Conditions

Chronic Wounds

Study ID

NCT03793062

Start date

Dec 4, 2018

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

256 participants

Anticipated

Interventions and Outcome Measures

Interventions

No Interventions

Not applicable - No Interventions

Primary outcome measure

  • 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 ]
  • Wound specific genetic changes using whole genome approaches. [ Time Frame: 16 weeks or healing whichever comes first ]
  • Identify specific SEEBIN factors. [ Time Frame: 16 weeks or healing whichever comes first ]

Central Contacts and Locations

Central contacts

Piya Das Ghatak, PhD, MS

412-648-8297piya.dasghatak@pitt.edu

Sashwati Roy, PhD

412-648-8297sar453@pitt.edu

Locations

UPMC Wound Care Centers

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Piya Das Ghatak, PhD, MS

6149064621piya.dasghatak@pitt.edu

Urmila Gnyawali, CCRP

614-371-2028usg2@pitt.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

  • genome
  • epigenome
  • chronic wounds
  • genetics
  • socioeconomic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-04-14.