BridgeMD
New treatment option for Claudication
Official title The Effects of Diet and Exercise Interventions in Peripheral Artery Disease
ClinicalTrials.gov ID: NCT03845036
What this study is testing
- What it's testing
- This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the DASH dietary program combined with a home-based exercise program, quantified by a step activity monitor, to improve exercise and vascular outcome measures in patients with PAD.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- History of claudication,
- Presence of PAD, defined by meeting at least one of the following criteria (ABI at rest \ 20% decrease in ABI following a heel-rise exercise test in...
You likely can't join if
- absence of PAD, defined by meeting all of the following 3 criteria (ABI at rest \> 0.90), \< 20% decrease in ABI following a heel-rise exercise test...
- non-compressible vessels (ABI \> 1.40),
- rest pain due to PAD (Fontaine stage III; Rutherford Grade II),
- tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III),
- use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to...
- peripheral revascularization within one month prior to investigation,
See the full eligibility criteria
- History of claudication,
- Presence of PAD, defined by meeting at least one of the following criteria (ABI at rest \ 20% decrease in ABI following a heel-rise exercise test in patients with a normal ABI at rest (\> 0.90), or history of peripheral...
- absence of PAD, defined by meeting all of the following 3 criteria (ABI at rest \> 0.90), \< 20% decrease in ABI following a heel-rise exercise test, and no history of peripheral revascularization,
- non-compressible vessels (ABI \> 1.40),
- rest pain due to PAD (Fontaine stage III; Rutherford Grade II),
- tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III),
- use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,
- peripheral revascularization within one month prior to investigation,
- active cancer,
- end stage renal disease defined as stage 5 chronic kidney disease,
- medical conditions that are contraindicative for exercise according to the American College of Sports Medicine,
- cognitive dysfunction (mini-mental state examination score \< 24), and
- failure to complete the baseline tests within three weeks.
The study team makes the final eligibility decision.
Where it's taking place
- Oklahoma City, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oklahoma City, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.