Impact of Remote Foot Temperature Monitoring
Completed · Not applicable
Conditions studied: Foot Ulcer, Diabetic
In brief
One of the only evidence-based practices for the prevention of diabetic foot ulcer recurrence is once-daily foot temperature monitoring, which is recommended by multiple clinical practice guidelines for high-risk patients, including those with history of foot ulcers. The purpose of this research study is to evaluate the use of once-daily foot temperature monitoring to reduce the occurrence and recurrence of diabetic foot ulcers and reduce total health care utilization for diabetic patients with a foot ulcer that has healed in the past 24 months.
Key facts
- Study ID
- NCT04345016
- Run by
- Kaiser Permanente
- People needed
- 79
- Starts
- 2017-04-13
- Expected to finish
- 2019-11-30
- Last updated by the study team
- 2025-03-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- a diagnosis of diabetes mellitus (type 1 or 2)
- a history of diabetic foot ulcer or amputation which healed within the 24 months prior to enrollment
- adequate lower extremity vascular supply, defined as presence of palpable bilateral posterior tibial and dorsalis pedis pulses or an ankle brachial index exceeding 0.5 documented within the 12 months preceding study enrollment
- the ability to provide informed consent
You may not qualify if…
- baseline inflammatory foot conditions, including unhealed ulcer or lesion (dorsal or plantar), active Charcot arthropathy, ongoing foot infection, or ongoing cellulitis
- a history of amputation more proximal than a transmetatarsal amputation in either foot
- inability to ambulate without the assistance of a wheelchair, walker, or crutches
- travel plans expected to interrupt the use of the study device for longer than two consecutive weeks
- any condition which, in the investigator's judgment, rendered the patient unsuitable or unreliable for participation.
Where it is running
- Kensington Medical Center — Kensington, Maryland, United States
- Largo Medical Center — Upper Marlboro, Maryland, United States
- Springfield Medical Center — Springfield, Virginia, United States
Full record on ClinicalTrials.gov
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