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NCT Number: NCT00777712

Mechanisms Underlying Impaired Diabetic 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.

Recruiting

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Key information

Conditions

Non-healing Wound Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC Montefiore, Pittsburgh, Pennsylvania, United States

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About this study

Specific aims:

  • To study biology of wound derived inflammatory cells and fluid from diabetic versus non diabetic wounds.
  • To characterize mechanisms that are responsible for dysregulated wound inflammatory cell function in individuals with diabetes.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Draw

Other

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

Primary outcomes

  1. Wound healing

    Time frame: Week 16

    Wound healing status

Secondary outcomes

  1. Infection status

    Time frame: week 0

    CFU analysis of the wound fluid

Study contacts

Contact information is provided by the study sponsor or research team.

Piya Das Ghatak, PhD, MS

CONTACT

[email protected]

412-648-8297

Urmila Gnyawali

CONTACT

[email protected]

4126240422

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Mechanisms Underlying Impaired Wound Healing

Acronym: WoundVAC

Important dates

Study start
2008
Primary completion
2029
Study completion
2030
First posted
Oct 22, 2008
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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