Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT00777712

Conditions

Non-healing Wound

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Blood draw

Study Details

Brief summary:

The overall aim of this research is to utilize wound derived inflammatory cells from diabetic versus non diabetic human chronic wounds to understand mechanisms that are responsible for disregulated inflammation in individuals with diabetes. Biology of normal (peripheral blood derived cells) versus wound derived cells will also be studied.

Conditions

Non-healing Wound

Study ID

NCT00777712

Start date

Sep 1, 2008

Status verified date

Jun, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ages 21-80
  • Chronic Wound (present >4 weeks)
  • Diabetic \& Non-diabetic
  • Adult surgical wounds

Exclusion Criteria:

  • Inability to consent
  • Pregnant women
  • Therapeutically immunocompromised
  • Individuals defined in 45 CFR 46 Subparts B,C, and D, nor from any other population considered vulnerable 2.9

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Chronic wound study

Patients with diabetes or no diabetes

Interventions

Blood draw

Blood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care).

Primary outcome measure

  • Wound healing [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

Piya Das Ghatak, PhD, MS

412-648-8297pid12@pitt.edu

Urmila Gnyawali

4126240422USG2@pitt.edu

Locations

UPMC Montefiore

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

CeCe Zamarripa, RN

412-647-7728zamarripaca@upmc.edu

Piya Das Ghatak, PhD

4126240422piya.dasghatak@pitt.edu

UPMC Presbyterian

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Cecilia Zamarripa, RN

412-647-7728zamarripaca@upmc.edu

Piya Das Ghatak, PhD

412-648-8297pid12@pitt.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • Wound healing
  • diabetes
  • inflammatory cell
  • monocyte
  • leukocyte
  • macrophage

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 2026-06-05.