Mechanisms Underlying Impaired Diabetic Wound Healing (WoundVac)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Ohio State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sashwati Roy, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00777712
First received: October 21, 2008
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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 Intervention
Non-healing Wounds
Diabetes
Other: Blood draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanisms Underlying Impaired Diabetic Wound Healing

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Determine molecular mechanisms underlying impaired wound healing in diabetes [ Time Frame: Same day as collection for each subject, one year for completion of overall results ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize differences in biology between normal peripheral blood derived cells and wound derived cells. [ Time Frame: One day for each experiment (begins after each collection), one year for characterization ] [ Designated as safety issue: No ]
  • Characterize mechanisms responsible for dysregulated wound inflammatory cell function in patients with diabetes [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood, Wound Vac Sponge.


Estimated Enrollment: 150
Study Start Date: September 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
5
Poorly controlled diabetes in patients with HbA1c level >8% who have wound (s) 4 weeks or longer with infection. Number of subjects will be enrolled 25 in this group.
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).
1
Non-Diabetic patients with wound(s) 4 weeks or longer with infection (n= 25). Number of subjects will be enrolled 25 in this group.
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).
6
Poorly controlled diabetes in patients with HbA1c level >8% who have wound (s) 4 weeks or longer without infection. Number of subjects will be enrolled 25 in this group.
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).
2
Non-Diabetic patients with wound(s)4 weeks or longer without infection (n= 25). Number of subjects will be enrolled 25 in this group.
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).
3
Patients with controlled diabetes with HbA1c level<8% who have wound (s) 4 weeks or longer and also with infection. Number of subjects will be enrolled 25 in this group.
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).
4
Patients with controlled diabetes with HbA1c level <8% who have wound (s) 4 weeks or longer and also without infection. Number of subjects will be enrolled 25 in this group.
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).

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.

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited at the Comprehensive Wound Care Centers: Martha Morehouse Medical Plaza, OSU East, and University Hospitals

Criteria

Inclusion Criteria:

  • Age 25-80 years
  • Chronic Wound (present >4 weeks)
  • Diabetic & Non-diabetic

Exclusion Criteria:

  • Inability to consent
  • Pregnant women
  • Therapeutically immunocompromised
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777712

Contacts
Contact: Amy Hoover, LPN 614-293-0390 amy.hoover@osumc.edu
Contact: Elizabeth Murphy, BS 614-685-3173 elizabeth.murphy@osumc.edu

Locations
United States, Ohio
Comprehensive Wound Care Centers Recruiting
Columbus, Ohio, United States, 43210
Contact: Amy Hoover, LPN    614-293-0390    amy.hoover@osumc.edu   
Sub-Investigator: Gayle Gordillo, M.D.         
Sponsors and Collaborators
Sashwati Roy
Investigators
Principal Investigator: Sashwati Roy, Ph.D. Ohio State University
  More Information