Mechanisms Underlying Impaired Diabetic Wound Healing (WoundVAC)

Mechanisms Underlying Impaired Wound Healing

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.

Study Overview

• Status: Recruiting
• Conditions: Non-healing Wound
• Intervention / Treatment: Other: Blood draw

Detailed Description

Specific aims:

1. To study biology of wound derived inflammatory cells and fluid from diabetic versus non diabetic wounds.
2. To characterize mechanisms that are responsible for dysregulated wound inflammatory cell function in individuals with diabetes.
3. To characterize differences in the biology of normal peripheral blood derived cells versus wound derived cells.

The long-term goal of this study is to determine the molecular mechanisms underlying impaired wound healing in diabetics.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Piya Das Ghatak, PhD, MS; Phone Number: 412-648-8297; Email: pid12@pitt.edu
• Study Contact Backup: Name: Urmila Gnyawali; Phone Number: 4126240422; Email: USG2@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • Recruiting
      • UPMC Montefiore
      • Contact: Piya Das Ghatak, PhD; Phone Number: 4126240422; Email: piya.dasghatak@pitt.edu
      • Contact: CeCe Zamarripa, RN; Phone Number: 412-647-7728; Email: zamarripaca@upmc.edu
    • Pittsburgh, Pennsylvania, United States, 15219
      • Recruiting
      • UPMC Presbyterian
      • Contact: Cecilia Zamarripa, RN; Phone Number: 412-647-7728; Email: zamarripaca@upmc.edu
      • Contact: Piya Das Ghatak, PhD; Phone Number: 412-648-8297; Email: pid12@pitt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic wound study; Patients with diabetes or no diabetes	Other: Blood draw; Blood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing	Wound healing status	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection status	CFU analysis of the wound fluid	week 0

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Sashwati Roy, Ph.D., University of Pittsburgh

Publications and helpful links

General Publications

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

Helpful Links

• IU Center for Regenerative Medicine and Cell Based Therapies

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2008
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: October 21, 2008
• First Submitted That Met QC Criteria: October 21, 2008
• First Posted (Estimated): October 22, 2008

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: diabetes; Wound healing; macrophage; monocyte; inflammatory cell; leukocyte
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: STUDY23070132