NCT00777712

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Sep 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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 Progress80%
Sep 2008Dec 2030

Study Start

First participant enrolled

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
21.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

21.3 years

First QC Date

October 21, 2008

Last Update Submit

June 3, 2026

Conditions

Non-healing Wound

Keywords

Wound healingdiabetesinflammatory cellmonocyteleukocytemacrophage

Outcome Measures

Primary Outcomes (1)

  • Wound healing

    Wound healing status

    Week 16

Secondary Outcomes (1)

  • Infection status

    week 0

Study Arms (1)

Chronic wound study

Patients with diabetes or no diabetes

Other: Blood draw

Interventions

Blood drawOTHER

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

Chronic wound study

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients are being recruited at the UPMC Montefiore. The study started at the Ohio State University, and then moved to Indiana University before moving to University of Pittsburgh in 2023.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UPMC Montefiore

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

Related Publications (5)

  • Mousley M. Diabetes and its effect on wound healing and patient care. Nurs Times. 2003 Oct 21-27;99(42):70, 73-4.

    PMID: 14618996BACKGROUND

  • Stadelmann WK, Digenis AG, Tobin GR. Impediments to wound healing. Am J Surg. 1998 Aug;176(2A Suppl):39S-47S. doi: 10.1016/s0002-9610(98)00184-6.

    PMID: 9777971BACKGROUND

  • Meehan M, O'Hara L, Morrison YM. Report on the prevalence of skin ulcers in a home health agency population. Adv Wound Care. 1999 Nov-Dec;12(9):459-67.

    PMID: 10687558BACKGROUND

  • American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2007 Jan;30 Suppl 1:S42-7. doi: 10.2337/dc07-S042. No abstract available.

    PMID: 17192378BACKGROUND

  • American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41. doi: 10.2337/dc07-S004. No abstract available.

    PMID: 17192377BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Wound VAC Sponge from NPWT.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Sashwati Roy, Ph.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Piya Das Ghatak, PhD, MS

CONTACT

412-648-8297pid12@pitt.edu

Urmila Gnyawali

CONTACT

4126240422USG2@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

October 21, 2008

First Posted

October 22, 2008

Study Start

September 1, 2008

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Last Updated

June 5, 2026

Record last verified: 2026-06

Locations

US(2)