Monitoring foot temperature to prevent diabetic foot ulcers
Home Foot-temperature Monitoring Through Smart Mat Technology to Improve Access, Equity, and Outcomes in High-risk Patients With Diabetes
This study tests if using a smart mat to monitor foot temperature can help prevent diabetic foot ulcers in Veterans better than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 4 sites (Hines, Illinois and 3 other locations) |
| Trial ID | NCT05728411 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a remote foot temperature monitoring system designed to reduce the recurrence of diabetic foot ulcers in Veterans. Utilizing a smart mat that wirelessly transmits temperature data, the study compares this intervention against usual care over a period of 24 months. The research aims to assess primary outcomes such as ulceration rates, as well as secondary outcomes including hospitalization and quality of life. Additionally, the study will analyze the costs associated with remote monitoring versus traditional care methods.
Who should consider this trial
Good fit: Ideal candidates for this study are Veterans with diabetes who have a history of foot ulcers or lower extremity amputations.
Not a fit: Patients with dementia, those unable to ambulate, or individuals currently using in-home temperature monitoring may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of diabetic foot ulcers and improve overall health outcomes for Veterans.
How similar studies have performed: Other studies have shown promise with remote temperature monitoring in preventing diabetic foot ulcers, but this specific application within the VA system is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veteran * Diabetes diagnosis * History of foot ulcer (including active ulcer) OR history of lower extremity amputation (including unhealed amputation) * Able to understand/read English Exclusion Criteria: * Dementia * Unable to ambulate * Bilateral lower extremity amputation * Ankle brachial index \<0.6 or toe brachial index \<0.5 * Currently using in-home temperature monitoring * Prisoner
Where this trial is running
Hines, Illinois and 3 other locations
- Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States (Recruiting)
- Richmond VA Medical Center, Richmond, VA — Richmond, Virginia, United States (Recruiting)
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States (Recruiting)
- Spokane VA Medical Center, Spokane, WA — Spokane, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Alyson J. Littman, PhD MPH — VA Puget Sound Health Care System Seattle Division, Seattle, WA
- Study coordinator: Rachel M Thomas
- Email: Rachel.Thomas3@va.gov
- Phone: (206) 277-4161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.