Mechanisms Underlying Impaired Diabetic Wound Healing

Diabetes Clinical Trial

— WoundVac  

Official title:

Mechanisms Underlying Impaired Diabetic Wound Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777712
• Other study ID #: 1901962183
• Status: Completed
• Start date: September 1, 2008
• Est. completion date: June 13, 2023

Study information

• Verified date: April 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Non-healing Wounds
• Wounds and Injuries

Intervention

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).

Locations

Country	Name	City	State
United States	Comprehensive Wound Care Centers	Columbus	Ohio
United States	Comprehensive Wound Care Centers	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sashwati Roy

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View Citation

Mousley M. Diabetes and its effect on wound healing and patient care. Nurs Times. 2003 Oct 21-27;99(42):70, 73-4. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine molecular mechanisms underlying impaired wound healing in diabetes		Same day as collection for each subject, one year for completion of overall results
Secondary	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
Secondary	Characterize mechanisms responsible for dysregulated wound inflammatory cell function in patients with diabetes		one year

External Links

•   IU Center for Regenerative Medicine and Cell Based Therapies