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Remote Temperature Monitoring for Diabetic Foot Care (STOP Trial)
N/A
Recruiting
Led By Alyson J. Littman, PhD MPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Veteran with diabetes diagnosis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6,12, 18 and 24 months
Awards & highlights
STOP Trial Summary
This trial aims to test a "smart" mat that can reduce the risk of diabetic foot ulcer recurrence. It will also evaluate how well it is accepted and used in the VA.
Who is the study for?
This trial is for Veterans with diabetes who can read English and have had either a lower extremity amputation or foot ulcer in the past 24 months. It's not for those with dementia, prisoners, current users of in-home temperature monitoring, non-ambulatory individuals, or those with severe peripheral arterial disease.Check my eligibility
What is being tested?
The study tests if a 'smart' mat that monitors foot temperature and sends data to a remote team helps prevent ulcers compared to usual care. The goal is to see if this tech makes it easier and more effective for patients to monitor their condition.See study design
What are the potential side effects?
Since this trial involves remote monitoring rather than medication or invasive procedures, there are no direct side effects from the intervention itself.
STOP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a veteran diagnosed with diabetes.
STOP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6,12, 18 and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6,12, 18 and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of foot ulceration
Secondary outcome measures
Mean or median quality of life scores
Mean or median satisfaction with care scores
Mean or median self-efficacy for diabetes
+1 moreOther outcome measures
Utilization (outpatient visits, emergency room visits, hospitalizations) - any vs. none and number
STOP Trial Design
2Treatment groups
Experimental Treatment
Group I: Remote temperature monitoring + enhanced usual careExperimental Treatment2 Interventions
Enrollment in remote foot temperature monitoring in addition to enhanced usual care (described below)
Group II: Enhanced usual careExperimental Treatment1 Intervention
Usual care is based on the VA's amputation prevention program (PAVE - Preventing Amputation in Veterans Everywhere - VHA Directive 1410), which provides a model of care for patients at risk for amputation as well as patients who have already undergone an amputation.
Usual care will be enhanced by providing resources (e.g., information through written newsletters) relevant to a population of Veterans with diabetes, including information on nutrition and cooking, physical activities, and Whole Health opportunities
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,304,484 Total Patients Enrolled
5 Trials studying Diabetic Foot
530 Patients Enrolled for Diabetic Foot
Alyson J. Littman, PhD MPHPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
3 Previous Clinical Trials
4,888 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have dementia.I am a veteran diagnosed with diabetes.I regularly monitor my temperature at home.I had a leg amputation up to 2 years ago, and it may not be fully healed.Your ankle or toe blood pressure is too low.I cannot walk on my own.I have had both of my legs amputated.I have had a foot ulcer within the last 24 months.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced usual care
- Group 2: Remote temperature monitoring + enhanced usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
May I be part of this experiment?
"Aspiring participants to this trial must have diabetic foot and be aged between 18-89. In total, about 800 individuals are sought for the clinical trial."
Answered by AI
Does this clinical trial invite elderly patients to participate?
"This clinical trial has an age limit of 18-89, though there are 4 trials for minors and 123 studies specifically targeting elderly populations."
Answered by AI
Are there any further openings available in this medical experiment?
"The details of this clinical trial, which was published on March 20th 2022 and last amended on February 3rd 2023 reveal that the study is no longer recruiting participants. Nevertheless, there are 125 other trials actively accepting candidates at present."
Answered by AI
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