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Impact of Remote Foot Temperature Monitoring

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ClinicalTrials.gov Identifier: NCT04345016
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Collaborator:
Kaiser Permanente Mid-Atlantic States Mid-Atlantic Permanente Medical Group and Research Institute
Information provided by (Responsible Party):
Podimetrics, Inc.

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 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.

Condition or disease Intervention/treatment Phase
Foot Ulcer, Diabetic Device: Once-daily remote foot temperature monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The investigators evaluated diabetic foot-related outcomes and associated resource utilization for each participant during three distinct phases: the two years before study participation, the one year during the foot temperature monitoring intervention, and the period after the intervention ended through the date of the analysis (January, 2020).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Remote Monitoring of Healed Diabetic Foot Ulcers With Podimetrics Temperature Monitoring System for Prevention of Diabetic Foot Ulcers
Actual Study Start Date : April 13, 2017
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All Participants
Eligible participants were provided a once-daily remote foot temperature monitoring mat (Podimetrics SmartMat; Podimetrics Inc., Somerville MA) during the intervention/treatment phase. Each was followed for one year or until study disenrollment, health plan disenrollment, death, or end of the study and follow-up period. Outcomes data from eligible participants from the two years prior to the intervention/treatment phase and the period of time after the intervention ended through the analysis date (2020-01-01) were evaluated. For this period, these participants received standard medical and diabetic foot care.
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.




Primary Outcome Measures :
  1. rate of diabetic foot ulcer recurrence in before phase of trial [ Time Frame: From two years before the date of enrollment until the date of enrollment, exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial ]
    temporal rate of new diabetic foot ulcers occurring to participants (total number of diabetic foot ulcers divided by the total exposure duration for the participants)

  2. rate of diabetic foot ulcer recurrence in during phase of trial [ Time Frame: From the date of enrollment until the participant completed one year using the study device, or until withdrawing consent, dropping out, dying, or disenrolling as a beneficiary of the health plan sponsoring the trial ]
    temporal rate of new diabetic foot ulcers occurring to participants (total number of diabetic foot ulcers divided by the total exposure duration for the participants)

  3. rate of diabetic foot ulcer recurrence in after phase of trial [ Time Frame: From completing use of the study device until the analysis date on Jan 1, 2020 (between six months and three years on average for participants), exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial ]
    temporal rate of new diabetic foot ulcers occurring to participants (total number of diabetic foot ulcers divided by the total exposure duration for the participants)


Secondary Outcome Measures :
  1. adherence in daily use of the study device [ Time Frame: From the date of enrollment until the participant completed one year using the study device, or until withdrawing consent, dropping out, dying, or disenrolling as a beneficiary of the health plan sponsoring the trial ]
    total number of uses during each unique day during the intervention divided by the total number of exposure days during the treatment phase of the study

  2. rate of inflammation episodes detected by the study device [ Time Frame: From the date of enrollment until the participant completed one year using the study device, or until withdrawing consent, dropping out, dying, or disenrolling as a beneficiary of the health plan sponsoring the trial ]
    total number of times the study device identified inflammation to participants during the treatment phase of the study divided by the total number of exposure days during the treatment phase of the study

  3. rate of severe diabetic foot ulcer recurrence in before phase of trial [ Time Frame: From two years before the date of enrollment until the date of enrollment, exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial ]
    temporal rate of new diabetic foot ulcers with classification > UT-1A on the University of Texas grading system occurring to participants (total number of diabetic foot ulcers with classification > UT-1A divided by the total exposure duration for the participants)

  4. rate of severe diabetic foot ulcer recurrence in during phase of trial [ Time Frame: From the date of enrollment until the participant completed one year using the study device, or until withdrawing consent, dropping out, dying, or disenrolling as a beneficiary of the health plan sponsoring the trial ]
    temporal rate of new diabetic foot ulcers with classification > UT-1A on the University of Texas grading system occurring to participants (total number of diabetic foot ulcers with classification > UT-1A divided by the total exposure duration for the participants)

  5. rate of severe diabetic foot ulcer recurrence in after phase of trial [ Time Frame: From completing use of the study device until the analysis date on Jan 1, 2020 (between six months and three years on average for participants), exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial ]
    temporal rate of new diabetic foot ulcers with classification > UT-1A on the University of Texas grading system occurring to participants (total number of diabetic foot ulcers with classification > UT-1A divided by the total exposure duration for the participants)

  6. rate of inpatient admissions in before phase of trial [ Time Frame: From two years before the date of enrollment until the date of enrollment, exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial ]
    temporal rate of hospital admissions (total number of hospitalizations divided by the total exposure duration for the participants)

  7. rate of inpatient admissions in during phase of trial [ Time Frame: From the date of enrollment until the participant completed one year using the study device, or until withdrawing consent, dropping out, dying, or disenrolling as a beneficiary of the health plan sponsoring the trial ]
    temporal rate of hospital admissions (total number of hospitalizations divided by the total exposure duration for the participants)

  8. rate of inpatient admissions in after phase of trial [ Time Frame: From completing use of the study device until the analysis date on Jan 1, 2020 (between six months and three years on average for participants), exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial ]
    temporal rate of hospital admissions (total number of hospitalizations divided by the total exposure duration for the participants)

  9. rate of outpatient visits in before phase of trial [ Time Frame: From two years before the date of enrollment until the date of enrollment, exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial ]
    temporal rate of outpatient visits (any department/specialty) (total number of outpatient visits divided by the total exposure duration for the participants)

  10. rate of outpatient visits in during phase of trial [ Time Frame: From the date of enrollment until the participant completed one year using the study device, or until withdrawing consent, dropping out, dying, or disenrolling as a beneficiary of the health plan sponsoring the trial ]
    temporal rate of outpatient visits (any department/specialty) (total number of outpatient visits divided by the total exposure duration for the participants)

  11. rate of outpatient visits in after phase of trial [ Time Frame: From completing use of the study device until the analysis date on Jan 1, 2020 (between six months and three years on average for participants), exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial ]
    temporal rate of outpatient visits (any department/specialty) (total number of outpatient visits divided by the total exposure duration for the participants)

  12. rate of lower extremity amputations in before phase of trial [ Time Frame: From two years before the date of enrollment until the date of enrollment, exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial ]
    temporal rate of lower extremity amputations (total number of amputations divided by the total exposure duration for the participants)

  13. rate of lower extremity amputations in during phase of trial [ Time Frame: From the date of enrollment until the participant completed one year using the study device, or until withdrawing consent, dropping out, dying, or disenrolling as a beneficiary of the health plan sponsoring the trial ]
    temporal rate of lower extremity amputations (total number of amputations divided by the total exposure duration for the participants)

  14. rate of lower extremity amputations in after phase of trial [ Time Frame: From completing use of the study device until the analysis date on Jan 1, 2020 (between six months and three years on average for participants), exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial ]
    temporal rate of lower extremity amputations (total number of amputations divided by the total exposure duration for the participants)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345016


Locations
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United States, Maryland
Kensington Medical Center
Kensington, Maryland, United States, 20895
Largo Medical Center
Upper Marlboro, Maryland, United States, 20774
United States, Virginia
Springfield Medical Center
Springfield, Virginia, United States, 22150
Sponsors and Collaborators
Podimetrics, Inc.
Kaiser Permanente Mid-Atlantic States Mid-Atlantic Permanente Medical Group and Research Institute
Investigators
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Principal Investigator: Adam Isaac, DPM Kaiser Permanente Mid-Atlantic States Mid-Atlantic Permanente Medical Group
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Podimetrics, Inc.
ClinicalTrials.gov Identifier: NCT04345016    
Other Study ID Numbers: MA-16-134
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available upon reasonable request for research purposes by request to the Study Official (Adam Isaac, DPM) contingent upon approval by Kaiser Permanente Mid-Atlantic Permanente Research Institute.
Supporting Materials: Analytic Code
Time Frame: Data will be available beginning after peer review and publication.
Access Criteria: Data may be used for research purposes only. No commercial use permitted. It is available upon reasonable request of the Study Official (Adam Isaac, DPM) contingent upon approval by Kaiser Permanente Mid-Atlantic Permanente Research Institute.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Podimetrics, Inc.:
diabetic foot
diabetic foot ulcer
prevention
resource utilization
foot temperature monitoring
telemedicine
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases