Mechanisms Underlying Impaired Diabetic Wound Healing
ConditionNon-healing Wound
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-80
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 21-80
Chronic Wound (present >4 weeks)
Diabetic & Non-diabetic
Adult surgical wounds
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood draw
Other interventionBlood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care).
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Chronic wound study1 intervention
Trial outcomes
Primary outcomes
1
Wound healing
Wound healing status
Time frame
Week 16Secondary outcomes
1
Infection status
CFU analysis of the wound fluid
Time frame
week 0Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov