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Impact of Remote Foot Temperature Monitoring

NCT04345016 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2025-03-24

No results posted yet for this study

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 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.

Conditions

  • Foot Ulcer, Diabetic

Interventions

DEVICE

Once-daily remote foot temperature monitoring

Participants were provided a once-daily remote foot temperature monitoring mat (Podimetrics SmartMat; Podimetrics Inc., Somerville MA) which they used for one year or until dying, dropping out of the study, or disenrolling at a member of the health plan administering the study.

Sponsors & Collaborators

  • Mid-Atlantic Permanente Medical Group, P.C.

    collaborator UNKNOWN

  • Podimetrics, Inc.

    collaborator INDUSTRY

  • Mid-Atlantic Permanente Research Institute

    collaborator UNKNOWN

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Adam Isaac, DPM · Kaiser Permanente Mid-Atlantic States Mid-Atlantic Permanente Medical Group

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-13
Primary Completion
2019-11-30
Completion
2019-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04345016 on ClinicalTrials.gov