Status:
COMPLETED
Impact of Remote Foot Temperature Monitoring
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
Mid-Atlantic Permanente Medical Group, P.C.
Podimetrics, Inc.
Conditions:
Foot Ulcer, Diabetic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 f...
Detailed Description
Skin temperature monitoring as a useful tool to detect tissue at risk for breakdown and ulceration first emerged in the 1970s and has been examined by several investigators. For neuropathic wounds (ex...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04345016
Start Date
April 13 2017
End Date
November 30 2019
Last Update
March 24 2025
Active Locations (3)
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1
Kensington Medical Center
Kensington, Maryland, United States, 20895
2
Largo Medical Center
Upper Marlboro, Maryland, United States, 20774
3
Springfield Medical Center
Springfield, Virginia, United States, 22150