Clinical trial NCT00777712: Mechanisms Underlying Impaired Diabetic Wound Healing
Official title: Mechanisms Underlying Impaired Diabetic Wound Healing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-healing Wounds
Diabetes
Keywords: Wound healing
diabetes
inflammatory cell
monocyte
leukocyte
macrophage
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2008-10-22
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited at the Comprehensive Wound Care Centers: Indiana University/ Indiana University Health Hospitals

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.

Eligibility 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

Primary outcomes:
measure: Wound healing
timeFrame: Week 16
Secondary outcomes:
measure: Infection status
timeFrame: week 0
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Comprehensive Wound Care Centers
state: Indiana
city: Columbus
country: United States
facility: Comprehensive Wound Care Centers
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh - McKeesport
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh - Mercy
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh - Passavant
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sashwati Roy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mousley M. Diabetes and its effect on wound healing and patient care. Nurs Times. 2003 Oct 21-27;99(42):70, 73-4.
citation: Stadelmann WK, Digenis AG, Tobin GR. Impediments to wound healing. Am J Surg. 1998 Aug;176(2A Suppl):39S-47S. doi: 10.1016/s0002-9610(98)00184-6.
citation: Meehan M, O'Hara L, Morrison YM. Report on the prevalence of skin ulcers in a home health agency population. Adv Wound Care. 1999 Nov-Dec;12(9):459-67.
citation: American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2007 Jan;30 Suppl 1:S42-7. doi: 10.2337/dc07-S042. No abstract available.
citation: American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41. doi: 10.2337/dc07-S004. No abstract available.