SHOWME-PAD (Peripheral Artery Disease)

  • End date
    Dec 31, 2024
  • participants needed
  • sponsor
    Saint Luke's Health System
Updated on 21 April 2022
peripheral arterial diseases


The overall goal of SHOWME-PAD is to make the existing evidence-base on treatment outcomes -focusing on health status outcomes that reflect the patients' perspective - more transparently available to patients and providers, such that more informed, evidence-based shared treatment decisions occur. INTEGRITY-PAD has the potential to radically reorganize care delivery to patients with PAD such that more value for the patient and society will be created.


Peripheral arterial disease (PAD) is a burdensome condition that affects 10% of the population and increases to 15-20% among those ≥70 years. In PAD, the underlying pathophysiologic process, atherosclerosis, presents itself as blockages in patients' leg arteries that prevent adequate blood flow and can result in burning calf (or buttock) pain while walking and that is relieved upon rest ('intermittent claudication'). In extreme cases, PAD can progress to critical limb ischemia, characterized by ulceration, gangrene, and threatened limb viability. Patients with PAD have significant atherosclerotic risk factors and impaired health status - thus creating 2 therapeutic goals, prevention of cardiovascular events and improved symptom control and quality of life. While the onset of PAD tends not to be as abrupt as for other cardiovascular conditions, such as stroke or myocardial infarction, leg symptoms can severely affect patients' health status (their symptoms, functional status, and quality of life). In addition, patients' risk of having a cardiovascular event is disproportionately high, as compared with other cardiovascular diseases. One-year cardiovascular event rates - including cardiovascular death, myocardial infarction, or stroke, or other hospitalizations for atherothrombotic events - are estimated to be over 21% in patients with PAD, as compared with 15% for coronary artery disease and stroke.9 Mortality rates are 15-30% 5 years after diagnosis. Part of these disproportionate event rates may be explained by under recognition and under treatment of PAD and its underlying atherosclerotic process. Finally, PAD not only impacts patients' individual lives and their families; it also has a tremendous impact on society at large. It is estimated that annual costs associated with vascular-related hospitalizations in PAD patients in the US exceeds $21 billion.

The primary treatment goals for PAD are symptom relief, quality of life improvement, and cardiovascular risk reduction. Several treatment options are available for PAD, ranging from invasive revascularization procedures, including peripheral percutaneous intervention (PPI) and surgical revascularization to non-invasive options, including supervised and home-based exercise therapy, PAD-specific medications, and cardiovascular risk management. While there is no "gold-standard" treatment for PAD, less invasive options are recommended as a first-choice treatment. Despite these recommendations, invasive procedures are often first offered to patients, with no alternative options being discussed. In treatment scenarios with a lot of clinical equipoise (i.e. uncertainty about what treatment would be best) and a rapidly growing market for newly-introduced technologies, including medical devices for invasive PAD procedures (e.g. stents for endovascular treatment), with limited performance measurement and accountability criteria, there is a high risk of unwanted variation in treatment practices, misallocation of treatments, and unnecessary costs.

Given this context, some of the current challenges in current PAD care include: 1) limited access to the evidence-base in routine clinical care for patients and providers; 2) the potential mismatch of PAD treatments to patient preferences and profiles; and 3) patients not being informed or engaged in medical decision making. These challenges may leave patients uninformed about treatment risks and benefits, increase the risk of misallocating treatments to patients, and may unnecessarily increase costs. A very promising strategy to overcome these challenges is the use of evidence-based, decision support tools. Importantly, it is currently unknown whether patient-centered PAD decision-tools can be designed to improve the alignment of patients' values with respect to their treatment choice and whether these tools can improve patients' knowledge and access to the evidence-base related to PAD treatment and outcomes. The critical next step, therefore, is to create such tools and pilot their implementation as a foundation for broader integration of precision medicine and shared decision-making in clinical care.

Shared decision-making takes into account the latest evidence about all available treatment options and their outcomes, as well as patients' values and preferences with regards to treatment and potential outcomes that matter to them. Shared decision-making is extremely useful in treatment situations where there is clinical equipoise and where the choice of treatment should be greatly influenced by patients' preferences. Decision aids that facilitate this process of shared decision-making, have been consistently associated with better knowledge about the disease and treatments, less decisional conflict, and potential cost savings due to less invasive options being preferred by patients.

Condition Peripheral Artery Disease
Treatment Decision Support Tool
Clinical Study IdentifierNCT03190382
SponsorSaint Luke's Health System
Last Modified on21 April 2022


Yes No Not Sure

Inclusion Criteria

All race and ethnicity categories, English speaking, men and women
Age ≥18 years
New onset complaints of PAD symptoms or exacerbation of previous PAD symptoms
The diagnostic enrollment criterion includes a positive result for one of the following
Doppler resting ankle-brachial index (ABI)≤0.90 or a significant drop in post exercise ankle pressure of ≥20 mmHg

Exclusion Criteria

Non-compressible ankle-brachial index (ABI ≥ 1.30)
A lower limb revascularization procedure in the ipsilateral leg (same leg) where the patient is currently having symptoms in the past year (atherectomy, endarterectomy, bypass surgery, angioplasty)
Peripheral intervention that occurs before the baseline interview
Current episode of critical limb ischemia (ischemic rest pain, ulceration or gangrene) (Fontaine III, IV or Rutherford IV-VI)
Patients with dementia
Patients who are prisoners
Patients who are unable to provide informed consent
Non-English speaking patients
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note