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.
Peripheral arterial disease (PAD) is a prevalent illness that affects 12% of U.S adults.
Diabetes mellitus is one of the strongest atherosclerotic risk factors for this disease.
Among patients with diabetes mellitus, the prevalence of PAD is as high as 29%. An
underutilized component of care for PAD is walking therapy. Walking has specifically been
shown to improve functional status in patients with PAD and leg symptoms.
Leg symptoms in PAD include intermittent claudication and atypical leg symptoms (leg
discomfort other than intermittent claudication). Patients with symptomatic PAD have
impaired lower extremity functioning, which clinically manifests as slower walking speed,
reduced walking distance, and lower physical activity levels. These functional deficits
often hinder the ability to live independently in the community (e.g., walking to the bus
stop in time for the next bus, shopping independently for groceries). Reduced physical
activity is associated with an increased risk for mobility loss and a higher risk for
functional decline with subsequent inability to perform activities of daily living.
Walking therapy should not be a burden and it should be something that the patient can
routinely perform without the need for regular supervision, a treadmill, or to report to the
hospital (i.e., self-managed walking therapy). As patients with diabetes mellitus have
special needs for self-management behavior (e.g., diet, medication adherence) and, for those
with PAD, a higher burden of atypical leg symptoms, the role of a self-managed walking
program specific to this group of PAD patients cannot be overemphasized. Thus, this clinical
trial has 2 novel aspects: 1) to evaluate the role of self-managed walking therapy for
patients with symptomatic PAD and 2) to focus on patients with PAD and diabetes mellitus.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |