The Evidence

Learn how Bluedrop has been used to effectively reduce the burden of diabetic foot ulcers

Remote Temperature Monitoring is a proven method for reducing DFUs.

Analysis of Remote Temperature Monitoring techniques for high-risk individuals consistently demonstrate reduced diabetic foot ulceration and diabetic foot ulcer severity when strict protocols are implemented and followed by participants. Findings include:

  • Up to 40% of participants experience diabetic foot ulcer (DFU) recurrence within 12 months of prior ulcer healing1
  • 15-20% of people with a DFU require LEA (Lower Extremity Amputation)2
  • 5-year mortality following major amputations is ~50%3
  • 62–90% relative reduction in DFU occurrence when daily temperature monitoring is used as an early warning sign in high-risk patients4,5,6. Three foundational temperature-monitoring RCTs demonstrate:
    • DFU recurrence is frequent and severe.
    • Inflammation precedes ulceration and is detectable via temperature analysis.
    • Home temperature analysis reduces ulceration by 60–90% with effective patient engagement
    • Outcomes rely heavily on patient adherence to a labor-intensive manual protocol.
Publication STUDY Design Key Findings
Lavery et al., 2004
Home Monitoring of Foot Skin Temperatures to Prevent Ulceration Diabetes Single-blinded RCT, 6 months, 85 high-risk patientsCare4
  • 10× reduction in foot complications v. control (2% vs 20%)
  • Fewer ulcers and Charcot events
  • Failures linked to non-adherence, not device failure
Armstrong et al., 2007
 Skin Temperature Monitoring Reduces the Risk for Diabetic Foot Ulceration in High-Risk Patients Am J Med5 Physician-blinded RCT, 18 months, 225 high-risk patients (IWGDF Risk 2–3)
  • Thermometry group had ~3× lower ulcer risk vs standard care (4.7% vs 12.2%)
  • Temperature asymmetry ≥4°F predicted ulceration ~1 week prior
  • Significantly longer time-to-ulceration
Lavery et al., 2007
Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers Diabetes Care6 Multicenter, physician-blinded RCT, 15 months, 173 patients with prior ulcer history
  • Ulcer recurrence reduced ~4–5× (8.5% vs 29.3%) v. control
  • Temperature monitoring triggered early care-seeking and activity reduction
Frykberg et al., 2017 Diabetic foot ulcer prevention using a remote temperature monitoring mat Diabetes Care7 Prospective, multicenter observational study, 132 high-risk patients with prior DFU over ~8months, In-home daily SmartMat use
  • 97% sensitivity for detecting impending DFU
  • Median ~37 days lead time before clinical presentation
  • High patient usability with passive monitoring
Lavery et al., 2019 
Unilateral remote temperature monitoring to predict future ulceration for the diabetic foot in remission BMJ Open Diabetes Research & Care8 Prospective, multicenter study 
 129 IWGDF Risk 2–3 patients 
 Daily home monitoring
  • 86% sensitivity for ulcer detection
  • Median ~5 weeks lead time
  • Improved adherence vs manual thermometry
Brooks et al., 2021 Remote Diabetic Foot Temperature Monitoring: Cost-Effectiveness Analysis ClinicoEconomics and Outcomes Research9 Decision-tree health economic model comparing remote foot temperature monitoring (RFTM) + standard of care vs standard of care alone in moderate-to-high risk patients with diabetic neuropathy
  • RFTM + SoC was a dominant strategy vs SoC alone (cost-saving with better outcomes)
  • Estimated $38,593 saved per ulcer avoided and $8,027 saved per patient per year
  • Results robust across sensitivity analyses assuming ≥13% compliance
  • Suggests economic justification for remote temperature monitoring in DFU prevention programs
Real-World Resource Utilization & Health Economic Analyses10 Retrospective claims analysis 
Temperature monitoring program vs matched controls
  • ~50% reduction in hospitalization rates
  • Significant reduction in major amputations
  • Lower total cost of care per member per year
  • Net cost savings exceeding program cost

References

1. Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med 2017 376:2367-2375 | 2. McDermott K, Fang M, Boulton AJM, Selvin E, Hicks CW. Etiology, Epidemiology, and Disparities in the Burden of Diabetic Foot Ulcers. Diabetes Care 2023 46:209-221 | 3. Armstrong DG, Wrobel J, Robbins JM. Are diabetes-related wounds and amputations worse than cancer? Int Wound J 2007 4:286-287 | 4. Lavery LA, Higgins KR, Lanctot DR, et al. Home Monitoring of Foot Skin Temperatures to Prevent Ulceration. Diabetes Care 2004 27:2642-2647 | 5. Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Nixon BP, Boulton AJM. Skin Temperature Monitoring Reduces the Risk for Diabetic Foot Ulceration in High-Risk Patients. Am J Med 2007 120:1042-1046 | 6. Lavery LA, Higgins KR, Lanctot DR, et al. Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers. Diabetes Care 2007 30:14-20 | 7. Frykberg RG, Gordon IL, Reyzelman AM, et al. Diabetic foot ulcer prevention using a remote temperature monitoring mat. Diabetes Care 2017 40:973-980 | 8. Lavery LA, Petersen BJ, Linders DR, et al. Unilateral remote temperature monitoring to predict future ulceration for the diabetic foot in remission. BMJ Open Diabetes Res Care 2019 7:e000696 | 9. Brooks KR, Armstrong DG, Lavery LA. Remote Diabetic Foot Temperature Monitoring: Cost-Effectiveness Analysis. Clinicoecon Outcomes Res 2021 13:193-202 | 10. Isaac AL, McCaslin MA, Hodge MB, et al. 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 8:e001440

Bluedrop improves upon traditional Remote Temperature Monitoring by adding remote visual inspection

This evidence builds upon the predicate evidence by evaluating an at-home thermovisual foot scanner presented as a smart scale to participants, coupled with a remote monitoring and coaching service. The analysis of this solution aim to resolve issues with compliance, accessibility and data consistency from predicate studies, while replicating or improving upon the clinical and economic benefits assessed. The results of these analyses suggest the ability to:
  • Sustain high real-world adherence to home pedal monitoring with ~78% of patients scanning at least the recommended 3 times per week12-17 and ~98% scanning at least weekly17.
  • Identify risk factors sooner and suggest routine non-clinical preventative interventions patients can take outside of scheduled clinic visits to prevent DFU development.
  • Detect DFU formation on plantar foot surface sooner, with 100% of developing DFUs identified ahead of scheduled care15,16.
  • Effectively coach patients to resolve risks without clinical intervention: <1% of scans requiring escalation to the referring Healthcare Provider13,14,17.
  • Refer patients for clinical intervention early, with 100% of DFUs detected at Wagner Grade 115,16, reducing risk of hospitalization, advanced interventions and major amputation.
Publication STUDY Design Key Findings
Use of Thermovisual Monitoring for Prevention of Recurrence of DFU: Case Reports11 High-risk patients with prior DFU; home monitoring over 3 months
  • 85% of participants scanned daily (n=7)
  • Clinically significant lesions identified without corresponding temperature hotspots
  • Behavioural risk factors (e.g., walking barefoot) identified and addressed through remote coaching
Use of a Remote Thermovisual Monitoring System in High-Risk Patients12 High-risk DFU patients using the OneStep Foot Scanner at home without supplementary monitoring service; 27 patients with prior DFU history
  • 91% of patients scanned at least the  minimum suggested 3 times per week
  • 62% of elevated risks were resolved remotely
  • In post-escalation surveys, HCPs agreed or strongly agreed that scans helped identify issues earlier than standard care for 82% of escalations sent
  • 100% patient satisfaction among respondents who completed the end of study survey (n=23(85%))
Evaluating the Impact of a Remote Monitoring Service on Limb Salvage in Diabetic Foot Management and Care13 High-risk DFU patients using the OneStep Foot Scanner at home Patients enrolled in EveryStep monitoring service; 34 patients
  • Patients scanned on average every1.6 average days, or 4.4 times per week
  • 0.6% of scans required HCP escalation due to effective non-clinical intervention by monitoring service
  • 98% of identified risks were confirmed by visual analysis, while temperature-only signals accounted for 2% of risk findings
Evaluating the Impact of a Thermovisual Home Monitoring Solution to Detect Diabetic Foot Risk Factors for Early Intervention14 Real-world home monitoring population; 47 patients
  • 83% of monitored patients scanned > suggested 3 times per week
  • 0.7% of scans required HCP escalation due to effective non-clinical intervention by monitoring service
  • Annualized per patient monitoring encounters include 224 scans, 15 remote preventative engagements and 2 referrals to their Healthcare Provider
Exploring the Impacts of a Holistic Remote Monitoring Program for the Diabetic Foot Using a Novel Thermovisual Monitoring Device15 Longitudinal, high-risk cohort
  • Patients averaged 4.4 scans per week v. recommended 3 scans per week
  • Ulcer severity at detection for all ulcers was Wagner Grade 1
  • 24% of patients required HCP escalation ensuring that resource utilization and intensity was minimized
Watching the Foot Closely: Preliminary Observations from an Ongoing Study of Remote Monitoring in High-Risk Patients16 Retrospective, multi-site study; 62 patients, >90 days monitoring (interim analysis from 115 enrolled)
  • 67.7% of patients scanned ≥3×/week
  • 12 DFUs detected, all Wagner Grade 1 severity at time of detection
  • 50% of all DFUs identified ahead of routine clinic visits, 100% of DFUs on plantar surface (monitored area) identified ahead of routine clinic visits
Early Detection and Improved Access: Remote Diabetic Foot Monitoring as Part of a Diabetes Care Model17 Quality improvement initiative; real-world integration within NCQA-accredited Diabetes Management Program 44 high-risk patients
  • 77.3% scanned ≥3×/week, average 3.6 scans / week across all enrolled
  • 0.4% of scans required HCP escalation
  • Annualized per patient monitoring encounters include 186 scans, 6.7 coaching engagements, 2.3 escalations

References

  1. Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med 2017 376:2367-2375
  2. McDermott K, Fang M, Boulton AJM, Selvin E, Hicks CW. Etiology, Epidemiology, and Disparities in the Burden of Diabetic Foot Ulcers. Diabetes Care 2023 46:209-221
  3. Armstrong DG, Wrobel J, Robbins JM. Are diabetes-related wounds and amputations worse than cancer? Int Wound J 2007 4:286-287
  4. Lavery LA, Higgins KR, Lanctot DR, et al. Home Monitoring of Foot Skin Temperatures to Prevent Ulceration. Diabetes Care 2004 27:2642-2647
  5. Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Nixon BP, Boulton AJM. Skin Temperature Monitoring Reduces the Risk for Diabetic Foot Ulceration in High-Risk Patients. Am J Med 2007 120:1042-1046
  6. Lavery LA, Higgins KR, Lanctot DR, et al. Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers. Diabetes Care 2007 30:14-20
  7. Frykberg RG, Gordon IL, Reyzelman AM, et al. Diabetic foot ulcer prevention using a remote temperature monitoring mat. Diabetes Care 2017 40:973-980
  8. Lavery LA, Petersen BJ, Linders DR, et al. Unilateral remote temperature monitoring to predict future ulceration for the diabetic foot in remission. BMJ Open Diabetes Res Care 2019 7:e000696
  9. Brooks KR, Armstrong DG, Lavery LA. Remote Diabetic Foot Temperature Monitoring: Cost-Effectiveness Analysis. Clinicoecon Outcomes Res 2021 13:193-202
  10. Isaac AL, McCaslin MA, Hodge MB, et al. 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 8:e001440
  11. McIntosh C, Flynn S, O’Connell S, Scott R, Kirwan E. Use of Thermovisual Monitoring for Prevention of Recurrence of DFU: Case Reports. Presented at: International Symposium on the Diabetic Foot (ISDF); 2023; The Hague, The Netherlands
  12. Abbott CA, Franklin K, Stuart D, Kirwan E, Flynn S, Scott R, McIntosh C, Boulton AJM. Use of a Remote Thermovisual Monitoring System in High-Risk Patients: A Pilot Study. Presented at: American Diabetes Association (ADA) Scientific Sessions; 2024; Orlando, FL
  13. Scott R, Sandroussi C, Ryan M, Kiersey S. Evaluating the Impact of a Remote Monitoring Service on Limb Salvage Outcomes in Diabetic Foot Management and Care. Presented at: Great Debates and Updates on the Diabetic Foot (GDU DF); 2024; Dallas, TX
  14. Scott R, Sandroussi C, Ryan M, Kiersey S. Evaluating the Impact of a Thermovisual Home Monitoring Solution to Detect Diabetic Foot Risk Factors for Early Intervention. Presented at: Symposium on Advanced Wound Care (SAWC) Spring; 2025; Dallas, TX
  15. Bluedrop Medical. Exploring the Impacts of a Holistic Remote Monitoring Program for the Diabetic Foot Using a Novel Thermovisual Monitoring Device. Bluedrop White Paper Series White Paper 1 2025P
  16. Tapia Garcia L, Le L, Przybylski M, Neil M, Patel K, Ryan M, Scott R, Serena T. Watching the Foot Closely: Preliminary Observations from an Ongoing Study of Remote Monitoring in High-Risk Patients. Presented at: International Post-Acute Wound Care Society (IPAWS) Annual Meeting; 2025; New Orleans, LA
  17. Reyno J, Diaz D, Hall M, Sandroussi C. Early Detection and Improved Access: Remote Diabetic Foot Monitoring as Part of a Diabetes Care Model. Presented at: DFCon 2025 – Annual Conference of the American Limb Preservation Society (ALPS); 2025; Anaheim, CA