Diabetes Mellitus Clinical Trial
Official title:
Self-Managed Walking Improves Function in Patients With Diabetes Mellitus and Peripheral Arterial Disease
We are conducting a clinical research trial to determine the role of self-managed walking therapy to improve walking ability in patients with diabetes mellitus and peripheral arterial disease (PAD). PAD, commonly referred to as poor circulation in the legs, is a very common disease in patients with diabetes mellitus. For patients with PAD, there is a significant risk for poor walking ability and limb loss. One major treatment for PAD is walking therapy but the traditional methods for the delivery of this treatment have required frequent visits to a university or hospital-based site. We will address the role of self-managed walking program, to be conducted at or near the home, to improve limb function.
Status | Completed |
Enrollment | 145 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Age 40 years and older - Diabetes mellitus - Peripheral arterial disease - Leg symptoms Exclusion Criteria: - Myocardial infarction within 3 months of enrollment - Inability to walk for exercise secondary to chest pain, dyspnea, or poor balance - Prior major amputation |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | KU School of Medicine - Wichita | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center | American Diabetes Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal treadmill walking distance | 6 months | No |
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