Effectiveness of Remote Foot Temperature Monitoring

ConditionDiabetic Foot

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-89

SponsorVA Office of Research and Development

About this trial

Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural Veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Monitoring plantar foot temperatures is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poor because the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a "smart" mat that can wirelessly transmit data and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA. The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Veteran

Diabetes diagnosis

History of foot ulcer (including active ulcer) OR history of lower extremity amputation (including unhealed amputation)

Able to understand/read English

Disqualifiers

Dementia

Unable to ambulate

Bilateral lower extremity amputation

Ankle brachial index <0.6 or toe brachial index <0.5

Trial design

Design model

Parallel

Treatments tested in this trial

Remote foot temperature monitoring system
Other intervention
Remote temperature monitoring involves a thermometric mat that can detect "hot spots" on the plantar surface of the foot. The mat has embedded cellular connectivity so that data can be transmitted from the patient's home to the company, where the temperature data can be analyzed. The company has a team of health coaches that work with patients and providers to detect signs of damage early in order to prevent ulceration.
Enhanced usual care
Other 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

Treatment groups

800 Participants

are divided into 2 treatment groups

Group A: Remote temperature monitoring + enhanced usual careExperimental treatment 2 interventions

Group B: Enhanced usual careOther 1 intervention

Trial outcomes

Primary outcomes

Rate of foot ulceration

The primary outcome is the presence of new ulceration through 24 months

Time frame

24 months

Secondary outcomes

Rate of lower limb amputation

Any level of lower extremity amputation

Time frame

24 months

Mean or median quality of life scores

Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health v1.2. The global scale produces two scores: Global Mental Health and Global Physical Health. Raw scores are converted to T-score values (higher values indicate better health). Minimum and maximum T scores for Global Mental Health are 21.2 and 67.6, respectively. Minimum and maximum T scores for Global Physical Health are 16.2 and 67.7, respectively.

Time frame

6,12, 18 and 24 months

Mean or median satisfaction with care scores

Short assessment of patient satisfaction (SAPS) by Hawthorne G et al (2006) which includes 7 items. Each item is scored on a 0 to 4 scale. The score range is from 0 (extremely dissatisfied) to 28 (extremely satisfied).

Time frame

6,12, 18 and 24 months

Mean or median self-efficacy for diabetes

8-item Self-efficacy for diabetes measure that has a range of 1 to 10. Higher scores indicate higher self-efficacy.

Time frame

6, 12, 18, and 24 months

Other outcomes

Utilization (outpatient visits, emergency room visits, hospitalizations) - any vs. none and number

Based on electronic medical record data

Time frame

6, 12, 18, and 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov

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