Type2diabetes Clinical Trial
Official title:
Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
The goal of this study is to improve the therapeutic management of diabetic foot ulcers (DFU). The main questions to answer are if a program of non-weight bearing exercise helps the DFU heal faster than standard wound care. This randomized clinical trial will determine how blood flow to the ulcer and whole body metabolism may be improved with exercise. Participants will be randomized to either exercise + standard wound care or standard wound care alone and undergo testing for leg blood flow, fitness and measures of metabolism through blood draws. The intervention period is 6-weeks. Eligible participants must have an existing foot ulcer uncomplicated by infection and be medically cleared to exercise.
This research is being done because people with diabetes have reduced healing capacity. This can be problematic because wounds that do not heal may turn into ulcers which may lead to more severe complications. Non-weight bearing exercise has many positive health benefits that improve metabolic and vascular health which will then improve healing time. Therefore, the purpose of this study is to evaluate the positive effects of non-weight bearing exercise. Once the effects of non-weight bearing exercise are confirmed, progress towards the prevention and treatment of diabetic foot ulcers and complications may be possible. Potential participants are eligible for the study if diagnosed with type 2 diabetes and have a foot ulcer or wound. Approximately 40 subjects with Type 2 Diabetes are expected to complete this study. Participation in this study requires medical clearance following a screening visit and then being randomly assigned to a non-weight bearing exercise training group or a control group. Both groups will receive standard diabetic and wound care. Subjects will complete 7 study visits at the University of Michigan. The research tests during these visits will include measures of body composition, oral glucose tolerance test, exercise testing, blood draws, vascular function measurements, wound measurement, single-leg exercise session and group randomization If randomized to the Exercise Group subjects will be asked to visit the University of Michigan three days a week for 6 weeks. During each visit during this 6-week period, subjects will perform exercise training by completing 30 minutes of single-leg exercise at approximately 50% of a predetermined maximal effort. Regardless of the group subjects are randomized to, all will receive standard care for the management of diabetes foot ulcer/wound. ;