Understanding why diabetic wounds heal poorly
Mechanisms Underlying Impaired Diabetic Wound Healing
This study is trying to understand why wounds heal poorly in people with diabetes by looking at the differences in certain cells from their wounds compared to those from people without diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 5 sites (Indianapolis, Indiana and 4 other locations) |
| Trial ID | NCT00777712 on ClinicalTrials.gov |
What this trial studies
This research aims to investigate the inflammatory cells derived from chronic wounds in diabetic and non-diabetic individuals to uncover the mechanisms behind impaired wound healing in diabetes. It will compare the biology of these wound-derived cells with normal peripheral blood cells to identify differences in their function. The study will involve blood draws from participants with chronic wounds lasting more than four weeks, focusing on both diabetic and non-diabetic patients. The ultimate goal is to elucidate the molecular pathways that contribute to the dysregulated inflammation seen in diabetic wound healing.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21-80 with chronic wounds lasting more than four weeks, both diabetic and non-diabetic.
Not a fit: Patients who are pregnant, immunocompromised, or unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for chronic wounds in diabetic patients.
How similar studies have performed: Other studies have explored similar mechanisms of wound healing in diabetes, but this specific approach may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Indianapolis, Indiana and 4 other locations
- Comprehensive Wound Care Centers — Indianapolis, Indiana, United States (Completed)
- Comprehensive Wound Care Centers — Columbus, Ohio, United States (Completed)
- University of Pittsburgh - McKeesport — Pittsburgh, Pennsylvania, United States (Recruiting)
- University of Pittsburgh - Mercy — Pittsburgh, Pennsylvania, United States (Recruiting)
- University of Pittsburgh - Passavant — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Sashwati Roy, Ph.D. — University of Pittsburgh
- Study coordinator: Josephine Vidic, BS
- Email: jbv9@pitt.edu
- Phone: 4126240422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.