Using a device to monitor foot temperature at home for diabetes patients
A Feasibility Study Assessing the Impact of At-home Infrared Temperature Monitoring (AITM) With Telemedicine Support in the Management of Patients With Potential for Diabetes Foot Ulceration
This study is testing whether a new at-home device that checks foot temperature can help people with diabetes avoid foot ulcers by spotting problems early.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NHS Greater Glasgow and Clyde Academic / other |
| Locations | 1 site (Glasgow) |
| Trial ID | NCT06032221 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to evaluate the acceptability of an at-home temperature monitoring device for patients at high risk of diabetic foot ulcers. Participants will receive training on using an infrared camera and smartphone to capture daily images of their feet, which will be reviewed by the research team. The study will last for 12 weeks, during which any identified temperature abnormalities will lead to further podiatry consultations and preventive care. The goal is to identify potential issues with the study design before a larger evaluation is conducted.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with type 1 or type 2 diabetes who are independently ambulatory and assessed as high risk for foot ulcers.
Not a fit: Patients with active foot ulcers, infections, or severe conditions that limit their ability to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance early detection of foot ulcers in diabetic patients, potentially preventing serious complications.
How similar studies have performed: While this specific approach is novel, similar studies using remote monitoring for diabetic foot care have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent * Male or Female \>/ = 18 years of age * Diabetes Mellitus type 1 or 2 according to WHO criteria * independently ambulatory * deemed high risk/ in remission via SCI diabetes foot risk stratification tool * expected to comply with study schedule Exclusion Criteria: * active foot ulcer or open amputation site * active Charcot Neuro-osteoarthropathy * active foot infection based on PEDIS classification criteria * amputation proximal to the Chopart joint in one or both feet * critical limb ischaemia (according to PEDIS classification) * severe illness that would make 6-month survival unlikely based on the clinical judgement of the physician or podiatrist * concomitant severe physical or mental conditions that limit the ability to follow the instructions of the study, based on the clinical judgement of the physician or podiatrist
Where this trial is running
Glasgow
- Queen Elizabeth University Hospital — Glasgow, United Kingdom (Recruiting)
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.