NCT03793062

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Dec 2018Dec 2028

Study Start

First participant enrolled

December 4, 2018

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

9.5 years

First QC Date

January 2, 2019

Last Update Submit

April 8, 2026

Conditions

Chronic Wounds

Keywords

genomeepigenomechronic woundsgeneticssocioeconomic

Outcome Measures

Primary Outcomes (3)

  • 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).

    16 weeks or healing whichever comes first

  • 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

    16 weeks or healing whichever comes first

  • 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.

    16 weeks or healing whichever comes first

Interventions

No InterventionsOTHER

Not applicable - No Interventions

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

256 clinically diagnosed chronic wound patients will be recruited for this study.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Wound Care Centers

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (10)

  • Singer AJ, Clark RA. Cutaneous wound healing. N Engl J Med. 1999 Sep 2;341(10):738-46. doi: 10.1056/NEJM199909023411006. No abstract available.

    PMID: 10471461BACKGROUND

  • Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.

    PMID: 19903300BACKGROUND

  • 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.

    PMID: 15062754BACKGROUND

  • Gottrup F. A specialized wound-healing center concept: importance of a multidisciplinary department structure and surgical treatment facilities in the treatment of chronic wounds. Am J Surg. 2004 May;187(5A):38S-43S. doi: 10.1016/S0002-9610(03)00303-9.

    PMID: 15147991BACKGROUND

  • Ti D, Li M, Fu X, Han W. Causes and consequences of epigenetic regulation in wound healing. Wound Repair Regen. 2014 May-Jun;22(3):305-12. doi: 10.1111/wrr.12160.

    PMID: 24844330BACKGROUND

  • Mann J, Oakley F, Akiboye F, Elsharkawy A, Thorne AW, Mann DA. Regulation of myofibroblast transdifferentiation by DNA methylation and MeCP2: implications for wound healing and fibrogenesis. Cell Death Differ. 2007 Feb;14(2):275-85. doi: 10.1038/sj.cdd.4401979. Epub 2006 Jun 9.

    PMID: 16763620BACKGROUND

  • Rahnama F, Shafiei F, Gluckman PD, Mitchell MD, Lobie PE. Epigenetic regulation of human trophoblastic cell migration and invasion. Endocrinology. 2006 Nov;147(11):5275-83. doi: 10.1210/en.2006-0288. Epub 2006 Aug 3.

    PMID: 16887905BACKGROUND

  • Zhang W, Shiraishi A, Suzuki A, Zheng X, Kodama T, Ohashi Y. Expression and distribution of tissue transglutaminase in normal and injured rat cornea. Curr Eye Res. 2004 Jan;28(1):37-45. doi: 10.1076/ceyr.28.1.37.23493.

    PMID: 14704912BACKGROUND

  • Ai L, Kim WJ, Demircan B, Dyer LM, Bray KJ, Skehan RR, Massoll NA, Brown KD. The transglutaminase 2 gene (TGM2), a potential molecular marker for chemotherapeutic drug sensitivity, is epigenetically silenced in breast cancer. Carcinogenesis. 2008 Mar;29(3):510-8. doi: 10.1093/carcin/bgm280. Epub 2008 Jan 3.

    PMID: 18174247BACKGROUND

  • Chernov AV, Sounni NE, Remacle AG, Strongin AY. Epigenetic control of the invasion-promoting MT1-MMP/MMP-2/TIMP-2 axis in cancer cells. J Biol Chem. 2009 May 8;284(19):12727-34. doi: 10.1074/jbc.M900273200. Epub 2009 Mar 13.

    PMID: 19286653BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Wound debrided tissue, Blood, and Saliva samples

Study Officials

  • Chandan K Sen, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Piya Das Ghatak, PhD, MS

CONTACT

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

Sashwati Roy, PhD

CONTACT

412-648-8297sar453@pitt.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 4, 2019

Study Start

December 4, 2018

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

US(1)