Online Wound Electronic Medical Record to Decrease Limb Amputations in Persons with Diabetes

Study ID
STU 062011-086

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact
Cecilia Lara
214-645-8923
cecilia.lara@utsouthwestern.edu

Principal Investigator
Lawrence Lavery

Summary

This is a prospective, longitudinal; two arm cluster randomized controlled clinical trial. in this study, all subjects within a site are randomized to usual Standard of Care (SoC) treatment either with or without the addition of the oWeMR. The primary objective is to compare lower limb amputation rates between subjects in the two study arms. Participating institutions will be classified by center type (Va hospital, tertiary care hospital, or community hospital). Within each stratum defined by center type, institutions will be randomly assigned (1:1) to the SoC study arm or the SoC+oWeMR arm. all subjects enrolled in the study from a particular institution will receive the treatment assigned to that institution.SoC includes the use of standardized practices for diagnosis and treatment of DFus. This may or may not include routine wound photography. ongoing healing progress will be recorded and reviewed either with the oWeMR or with conventional medical review based on standardized reporting templates. Subjects will have study visits during wound treatment phase for 6 months unless their wound heals, they are amputated, and or they withdraw from the study early. amputation will be considered a primary endpoint if the amputation occurs at any level on the same lower extremity as the index wound.
any subject as of 3/31/14, will complete their end of Study visit on or before 7/14/14.

Participant Eligibility

Number of subjects: 4800
2. Gender of Subjects: Males and Females
Age of Subjects: >=18 years old
Racial and Ethnic Origin: There will be no exclusions of racial and ethnic origin

Inclusion Criteria
1. Signed informed consent
2. Type 1 or Type 2 diabetes
2. A break in the skin on the foot >= 0.5cm
3. >= 18 years old
4. Hemoglobin A1c within the last 120 days