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New treatment option for Claudication
Official title The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease
ClinicalTrials.gov ID: NCT05712395
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 Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (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 assessed by the Walking Impairment Questionnaire,
- ambulatory leg pain in either one or both legs consistent with intermittent claudication confirmed during a screening graded treadmill test using the...
- an ABI \ 20% decrease in ankle systolic blood pressure in either one or both legs immediately following the treadmill exercise test.
- age \>= 40 years.
You likely can't join if
- absence of PAD (ABI \> 0.90 at rest and ankle systolic blood pressure \< 20% decrease after exercise,
- inability to obtain an ABI measure due to non-compressible vessels (ABI \> 1.40),
- asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test,
- rest pain due to PAD (Fontaine stage III)
- tissue loss due to PAD (Fontaine stage IV)
- use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to...
See the full eligibility criteria
- history of claudication assessed by the Walking Impairment Questionnaire,
- ambulatory leg pain in either one or both legs consistent with intermittent claudication confirmed during a screening graded treadmill test using the Gardner-Skinner protocol,
- an ABI \ 20% decrease in ankle systolic blood pressure in either one or both legs immediately following the treadmill exercise test.
- age \>= 40 years.
- absence of PAD (ABI \> 0.90 at rest and ankle systolic blood pressure \< 20% decrease after exercise,
- inability to obtain an ABI measure due to non-compressible vessels (ABI \> 1.40),
- asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test,
- rest pain due to PAD (Fontaine stage III)
- tissue loss due to PAD (Fontaine stage IV)
- 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, or peripheral revascularization performed during the study,
- exercise tolerance limited by any disease process other than PAD,
- active cancer,
- kidney failure defined as stage 5 chronic kidney disease,
- a calf skin fold measurement \> 25 mm, because of potential interference with the light path of the NIRS probe from penetrating the subcutaneous tissue,
- pulse arterial oxygen saturation of the index finger \< 95% because of potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange, and
- failure to complete the baseline run-in phase 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.