WoundVac: Mechanisms Underlying Impaired Diabetic Wound Healing

Sponsor

Sashwati Roy (Other)

Overall Status

Recruiting

CT.gov ID

NCT00777712

Collaborator

(none)

300

Enrollment

Location

171

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-healing Wounds Diabetes	Other: Blood draw

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Mechanisms Underlying Impaired Diabetic Wound Healing

Study Start Date :

Sep 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Diabetics (HbA1c level >8%) with infection Poorly controlled diabetes in patients with HbA1c level >8% who have wound (s) 4 weeks or longer with infection. N=50	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).
Normoglycemic- with infection Non-Diabetic patients with wound(s) 4 weeks or longer with infection. N=50	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).
Diabetics (HbA1c level >8%) without infection Poorly controlled diabetes in patients with HbA1c level >8% who have wound (s) 4 weeks or longer without infection. N=50	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).
Normoglycemic- without infection Non-Diabetic patients with wound(s)4 weeks or longer without infection. N=50	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).
Diabetics (HbA1c level<8%) with infection Patients with controlled diabetes with HbA1c level<8% who have wound (s) 4 weeks or longer and also with infection. N=50	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).
Diabetics (HbA1c level <8%) without infection Patients with controlled diabetes with HbA1c level <8% who have wound (s) 4 weeks or longer and also without infection. N=50	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).

Outcome Measures

Primary Outcome Measures

Determine molecular mechanisms underlying impaired wound healing in diabetes [Same day as collection for each subject, one year for completion of overall results]

Secondary Outcome Measures

Characterize differences in biology between normal peripheral blood derived cells and wound derived cells. [One day for each experiment (begins after each collection), one year for characterization]
Characterize mechanisms responsible for dysregulated wound inflammatory cell function in patients with diabetes [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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