Non-Weight Bearing Exercise For Accelerated Healing Of Diabetic Foot Ulcers

HUM00202034

Women and men are needed to help identify the effects of 6-weeks of non-weight bearing exercise on diabetic foot ulcer healing. 

Who can participate?

• Type 2 diabetics (women and men) possessing a diabetic wound/ulcer free of infection
• Non-smoker 
• English speaking
• Not currently pregnant or lactating

You will undergo/receive:

• Medical history and health examination
• Regular wound assessment
• Peripheral vascular function testing 
• Glucose testing
• Body composition assessment
• Free Parking
• Up to $350 upon completion of the study

STUDY DETAILS:
Preliminary Screening – Before participating in the study, you will undergo screening at the School of Kinesiology (SKB) consisting of three visits. The first appointment should take about 4.5 hours to complete and will include a resting electrocardiogram (EKG), oral glucose tolerance test, body composition assessment, graded exercise stress test, basic blood draw, urine pregnancy test (for pre-menopausal women), and detailed medical history survey. The second appointment should take about 3 hours to complete and will include a peripheral vascular assessment in response to exercise. The third appointment should take about 1.5 hours to complete and will include a peripheral neuropathy assessment.
If you are deemed eligible based on the results of the preliminary screening, you will be enrolled into our study. You will be randomly assigned to either the Aerobic Exercise (AE) or Control group after visit 2. Both groups will also receive standard diabetes care. The study consists of three (3) distinct phases: Baseline Testing, 6-Week Study Period, and Post Testing.

1. Baseline Testing: We want to assess your current level of health and fitness. We will measure your: body composition, peripheral vascular health, peripheral nerve health, blood sugar control, and response to an acute exercise test. These tests will involve blood sampling.
2. 6-Week Study Period: If you are assigned to the AE group, you will undergo 6 weeks of supervised exercise training (3x/week) at the University of Michigan School of Kinesiology (SKB). You will be performing one-legged aerobic-type exercise (i.e., cycling). Heart rate and blood pressure will be monitored during these exercise sessions. The AE group will also be asked to return at week 3 to re-evaluate your vascular response to exercise. If you are assigned to the Control group, you will be asked to resume your normal activities throughout the 6-week study period. 
3. Post Testing: We will perform all the same tests that we did at baseline testing described above in order to see how your health and fitness has changed after 6 weeks of exercise training or standard care.  

If interested please fill out our pre-screening questionnaire: umich.qualtrics.com/jfe/form/SV_ehcQcJUND6KVMbk

 

SPARX3: Study In Parkinson Disease of Exercise Phase 3 Clinical Trial

HUM00180641

We are seeking volunteers to participate in a clinical research trial to learn more about the effects of aerobic exercise on people with Parkinson’s disease.

Who can participate?

• Diagnosed with Parkinson’s disease within the last 3 years
• Age 40-80 years
• Not yet taking medication for your PD symptoms / No use of PD medication within past 60 days
• You do not plan to start medication for PD within the next 6 months
• Are willing to take part in a regular treadmill exercise program 4 times per week for 18 months and participate in study visits periodically for 24 months
• Generally healthy, without any uncontrolled or unstable cardiovascular, metabolic, or renal disease
• Does not have any disorders that interfere with their ability to perform endurance exercises
• Less than 120 minutes per week of moderate intensity endurance exercise in the last 6 months
• Not allergic to iodinated products or hypersensitive to DaTscan™ SPECT
• Not currently pregnant or plan to become pregnant or plan to become pregnant in next 12 months
• Are not already participating in a structured exercise program
• Able to travel to the University of Michigan periodically for study related visits

You will undergo/receive:

• Medical history and health examination
• Physical and cognitive assessments
• Questionnaires
• Blood draws
• Exercise tests
• DaTscan brain imaging
• Up to $300 upon completion of the study

STUDY DETAILS:

Preliminary Screenings – Before participating in the study, you will undergo screenings at the University of Michigan School of Kinesiology, Domino Farms and/or the University Hospital. The first screening visit will include a blood draw, questionnaires, a physical and neurological exam, a cognitive assessment, and detailed medical history survey. If you pass the first screening, you will have a DaTscan (brain imaging).

If you are deemed eligible based on the results of the preliminary screenings, you will be enrolled into our study.

The study consists of three (3) distinct phases: Baseline Testing, 18-Month Exercise Intervention, and Post Testing.

1. Baseline Visit: We want to determine your abilities prior to beginning study intervention. This visit will include another blood draw, questionnaires, a cognitive assessment, and exercise testing.
2. 18-Month Study Period: You will be randomly assigned to one of two exercise groups: moderate (60-65% HRmax) or high (80-85% HRmax) intensity. You will be performing aerobic treadmill exercise 4 times per week for 18 months. Heart rate will be monitored during these exercise sessions. You will begin exercising at our facility under the supervision of an exercise trainer. Once the exercise trainer determines you can perform the exercise safely and correctly on your own, you may complete your exercise sessions at home or another exercise facility of your choice. You will meet with the research team twice per month. You will also be asked to return every 3 months to re-evaluate several measures we collect throughout your study participation.
3. Post Testing: Your final study visit will take place around the 24-month time point. This visit will include an assessment of your current status and progression of your Parkinson’s disease, questionnaires, and a blood draw.

If interested, please contact Kendell Lewis at (734) 647-2706; [email protected].