Mechanisms Underlying Impaired Diabetic Wound Healing

Completed

• Conditions: Diabetes; Non-healing Wounds
• Interventions: Other: Blood draw

• Registration Number: NCT00777712
• Lead Sponsor: Dr. Sashwati Roy

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.

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 Timeline

• Study Start: 2008-09-01
• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-22
• Primary Completion: 2023-06-13
• Study Completion: 2023-06-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic wound study	Blood draw	Patients with diabetes or no diabetes

Primary Outcome Measures

Name	Time	Method
Wound healing	Week 16	Wound healing status

Secondary Outcome Measures

Name	Time	Method
Infection status	week 0	CFU analysis of the wound fluid

Trial Locations

Locations (4)

University of Pittsburgh - McKeesport; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Pittsburgh - Mercy; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Pittsburgh - Passavant; 🇺🇸 Pittsburgh, Pennsylvania, United States

Comprehensive Wound Care Centers; 🇺🇸 Columbus, Ohio, United States