NCT05968924

Brief Summary

The investigator team will study the adherence of the participant cohort to a non significant risk device over a six month period. The device is a foot mat, which can detect changes in foot temperature that may predict foot ulceration in patients with diabetes mellitus. This mat, the Podimetrics Smart Mat, is FDA cleared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

July 3, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2025

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 30, 2026

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

July 20, 2023

Results QC Date

April 3, 2026

Last Update Submit

April 27, 2026

Conditions

Diabetic Foot Ulcer

Keywords

DiabetesFoot UlcerPreventionInnovationDiabetic complicationsRemote temperature monitoring technologyChronic wounds

Outcome Measures

Primary Outcomes (1)

  • Adherence to Use of SmartMat

    Participant adherence to use of SmartMat will be quantified by automated data collection. Adherence is defined as having conducted \>3 days foot scans per week (foot scans/week) over the six-month period. The median number of scans/week over a six-month period is reported.

    Up to six months following intervention

Secondary Outcomes (2)

  • Use of Health Care Facilities

    Up to six months following intervention

  • Occurrence of Diabetic Foot Ulcer (DFU)

    Up to six months following intervention

Study Arms (1)

High risk Diabetic Foot Ulcer (DFU)

EXPERIMENTAL

Podimetrics smart map

Device: Podimetrics SmartMat

Interventions

Podimetrics SmartMatDEVICE

Participants receive training for stepping on SmartMat each day for 6 months. Monthly phone calls will be conducted to assess foot health and mat.

High risk Diabetic Foot Ulcer (DFU)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 or Type 2 diabetes mellitus
  • Prior treatment of DFU within 24 months
  • Subject had at least one outpatient follow up with a provider after treatment for DFU
  • No active ulcer at time of enrollment
  • Male or female, aged 18-75 yrs
  • Presence of Neuropathy
  • Ambulatory
  • Provision of signed and dated informed consent form
  • Stated willingness to adhere with all study procedures and availability to participate for the duration of the study

You may not qualify if:

  • Active diabetic foot ulcer (DFU)
  • Unable to comply with study requirements
  • Prior above-knee amputation (AKA) or below-knee amputation (BKA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (8)

  • Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Lavery LA. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Am J Med. 2007 Dec;120(12):1042-6. doi: 10.1016/j.amjmed.2007.06.028.

    PMID: 18060924BACKGROUND

  • Crocker RM, Palmer KNB, Marrero DG, Tan TW. Patient perspectives on the physical, psycho-social, and financial impacts of diabetic foot ulceration and amputation. J Diabetes Complications. 2021 Aug;35(8):107960. doi: 10.1016/j.jdiacomp.2021.107960. Epub 2021 May 23.

    PMID: 34059410BACKGROUND

  • Hoban C, Sareen J, Henriksen CA, Kuzyk L, Embil JM, Trepman E. Mental health issues associated with foot complications of diabetes mellitus. Foot Ankle Surg. 2015 Mar;21(1):49-55. doi: 10.1016/j.fas.2014.09.007. Epub 2014 Sep 22.

    PMID: 25682407BACKGROUND

  • 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: 33055233BACKGROUND

  • 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: 15504999BACKGROUND

  • Margolis DJ, Malay DS, Hoffstad OJ, Leonard CE, MaCurdy T, de Nava KL, Tan Y, Molina T, Siegel KL. Incidence of diabetic foot ulcer and lower extremity amputation among Medicare beneficiaries, 2006 to 2008. 2011 Feb 17. In: Data Points Publication Series [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011-. Data Points #2. Available from http://www.ncbi.nlm.nih.gov/books/NBK65149/

    PMID: 22049565BACKGROUND

  • Rothenberg GM, Page J, Stuck R, Spencer C, Kaplan L, Gordon I. Remote Temperature Monitoring of the Diabetic Foot: From Research to Practice. Fed Pract. 2020 Mar;37(3):114-124.

    PMID: 32317847BACKGROUND

  • Skafjeld A, Iversen MM, Holme I, Ribu L, Hvaal K, Kilhovd BK. A pilot study testing the feasibility of skin temperature monitoring to reduce recurrent foot ulcers in patients with diabetes--a randomized controlled trial. BMC Endocr Disord. 2015 Oct 9;15:55. doi: 10.1186/s12902-015-0054-x.

    PMID: 26452544BACKGROUND

MeSH Terms

Conditions

Diabetic FootDiabetes MellitusFoot UlcerDiabetes Complications

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesFoot Diseases

Limitations and Caveats

This study has limitations. The absence of a control group precludes assessment of the mat's efficacy in predicting DFU occurrences, limiting causal inference, which may limit generalizability of adherence to broader high-risk populations. Participant's adherence to offloading instructions was not systematically assessed and may represent a key factor influencing ulcer development despite recommended offloading.

Results Point of Contact

Title
Dr. Johanna Daily
Organization
Montefiore Medical Center
johanna.daily@einsteinmed.edu
7188780020

Study Officials

  • Johanna Daily, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 1, 2023

Study Start

July 3, 2024

Primary Completion

April 3, 2025

Study Completion

April 3, 2025

Last Updated

April 30, 2026

Results First Posted

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)