The primary objective of this study is to evaluate the effectiveness of traditional total contact casts (TCC), removable cast walkers (RCW) and a modification of a RCW, termed the instant total contact cast (ITCC). TCCs are the ideal gold standard to heal diabetic foot ulcers. Even though RCWs have been shown to be as effective as TCCs to reduce peak pressure on the sole of the foot, in clinical trials a smaller proportion of wounds heal, and the rate of healing is also slower than TCCs. We have demonstrated that this is because of poor compliance. Our pilot data indicates that by taking a RCW and covering it with an elastic bandage or cast tape, the removable device is irremovable and healing parameters are equivalent to TCCs. We plan to randomize 225 diabetics with foot ulcers into three treatment groups: TCC, ITCC and RCW to evaluate the proportion of healing in 20 weeks, the rate of healing, complications and cost of therapy. We will monitor activity with a computer activity monitor. To monitor compliance we will embed an activity monitor in the off-loading device and compare total activity to activity with the off-loading device. We believe that healing parameters will be the same in TCC and ITCC groups and both will be significantly better than the RCW group. In addition, we expect the ITCC to be less expensive than TCC.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK074483-05
Application #
8117646
Study Section
Musculoskeletal Rehabilitation Sciences Study Section (MRS)
Program Officer
Jones, Teresa L Z
Project Start
2007-05-01
Project End
2014-04-30
Budget Start
2011-05-01
Budget End
2014-04-30
Support Year
5
Fiscal Year
2011
Total Cost
$349,541
Indirect Cost
Name
University of Texas Sw Medical Center Dallas
Department
Plastic Surgery
Type
Schools of Medicine
DUNS #
800771545
City
Dallas
State
TX
Country
United States
Zip Code
75390