Impact of Remote Foot Temperature Monitoring

NCT04345016 | Completed FDA Device

• 1 other identifier: MA-16-134
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 3

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.

Conditions

Foot Ulcer, Diabetic

Keywords

diabetic foot; diabetic foot ulcer; prevention; resource utilization; foot temperature monitoring; telemedicine

Outcome Measures

Primary Outcomes (3)

• rate of diabetic foot ulcer recurrence in before phase of 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)

  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

• rate of diabetic foot ulcer recurrence in during phase of 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)

  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

• rate of diabetic foot ulcer recurrence in after phase of 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)

  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

Secondary Outcomes (14)

• adherence in daily use of the study device

  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

• rate of inflammation episodes detected by the study device

  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

• rate of severe diabetic foot ulcer recurrence in before phase of trial

  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

• rate of severe diabetic foot ulcer recurrence in during phase of trial

  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

• rate of severe diabetic foot ulcer recurrence in after phase of trial

  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

Study Arms (1)

All Participants

EXPERIMENTAL

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

Interventions

Once-daily remote foot temperature monitoring DEVICE

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.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Kaiser Permanente: lead
• Mid-Atlantic Permanente Medical Group, P.C.: collaborator
• Podimetrics, Inc.: collaborator
• Mid-Atlantic Permanente Research Institute: collaborator

Study Sites (3)

Kensington Medical Center

Kensington, Maryland, 20895, United States

Location

Largo Medical Center

Upper Marlboro, Maryland, 20774, United States

Location

Springfield Medical Center

Springfield, Virginia, 22150, United States

Location

Related Publications (8)

• Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Athanasiou KA, Armstrong DG, Agrawal CM. Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care. 2007 Jan;30(1):14-20. doi: 10.2337/dc06-1600.

  PMID: 17192326 BACKGROUND

• Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Armstrong DG, Athanasiou KA, Agrawal CM. Home monitoring of foot skin temperatures to prevent ulceration. Diabetes Care. 2004 Nov;27(11):2642-7. doi: 10.2337/diacare.27.11.2642.

  PMID: 15504999 BACKGROUND

• Gordon IL, Rothenberg GM, Lepow BD, Petersen BJ, Linders DR, Bloom JD, Armstrong DG. Accuracy of a foot temperature monitoring mat for predicting diabetic foot ulcers in patients with recent wounds or partial foot amputation. Diabetes Res Clin Pract. 2020 Mar;161:108074. doi: 10.1016/j.diabres.2020.108074. Epub 2020 Feb 25.

  PMID: 32109516 BACKGROUND

• Frykberg RG, Gordon IL, Reyzelman AM, Cazzell SM, Fitzgerald RH, Rothenberg GM, Bloom JD, Petersen BJ, Linders DR, Nouvong A, Najafi B. Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers. Diabetes Care. 2017 Jul;40(7):973-980. doi: 10.2337/dc16-2294. Epub 2017 May 2.

  PMID: 28465454 BACKGROUND

• Banks JL, Petersen BJ, Rothenberg GM, Jong AS, Page JC. Use of a Remote Temperature Monitoring Mat for the Early Identification of Foot Ulcers. Wounds. 2020 Feb;32(2):44-49.

  PMID: 32155121 BACKGROUND

• Killeen AL, Brock KM, Dancho JF, Walters JL. Remote Temperature Monitoring in Patients With Visual Impairment Due to Diabetes Mellitus: A Proposed Improvement to Current Standard of Care for Prevention of Diabetic Foot Ulcers. J Diabetes Sci Technol. 2020 Jan;14(1):37-45. doi: 10.1177/1932296819848769. Epub 2019 May 23.

  PMID: 31122064 BACKGROUND

• Killeen AL, Walters JL. Remote Temperature Monitoring in Diabetic Foot Ulcer Detection. Wounds. 2018 Apr;30(4):E44-E48.

  PMID: 29718822 BACKGROUND

• Isaac AL, Swartz TD, Miller ML, Short DJ, Wilson EA, Chaffo JL, Watson ES, Hu H, Petersen BJ, Bloom JD, Neff NJ, Linders DR, Salgado SJ, Locke JL, Horberg MA. Lower resource utilization for patients with healed diabetic foot ulcers during participation in a prevention program with foot temperature monitoring. BMJ Open Diabetes Res Care. 2020 Oct;8(1):e001440. doi: 10.1136/bmjdrc-2020-001440.

  PMID: 33055233 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Adam Isaac, DPM

  Kaiser Permanente Mid-Atlantic States Mid-Atlantic Permanente Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 14, 2020
• Study Start: April 13, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (3)