Quiz Response Summary

People with diabetes have a 34% chance of developing diabetic foot ulcers that can lead to amputation. (13)

Clinical evidence indicates that daily at-home foot temperature monitoring significantly reduce the risk of a diabetes‐related foot ulcer amongst patients at moderate or high risk. (6)

Based on these risk factors and available evidence, thermal foot monitoring provided by Feetsee is expected to have

HIGH BENEFIT

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Risk of Artery Disease Yes

Diabetes is a major risk factor for PAD, the disease associated with delayed or non-healing diabetic foot ulcers, increased risk of gangrene and amputation.(3)

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Here's Why Foot Health Matters

Temperature changes appear before visible wounds.

Rising foot temperature is an early warning sign that damage is starting internally. (8)

1 in 4 people with diabetes will develop a foot ulcer.

Foot ulcers are one of the most common and dangerous diabetes complications. (9)

80% of diabetes-related amputations begin with a foot ulcer

Early damage, if missed, can become irreversible. (10)

Up to 75% of diabetic foot ulcers are preventable

Earlier identification of inflammatory risk is critical to preventing skin breakdown. (11)

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How Foot Ulcers Develop

(12)

Stage 0 - Pre-ulcerative lesion

  • No open wound yet

  • High-risk foot with calluses, deformities, dry skin, or previous ulcer

  • Neuropathy or poor circulation is usually present

    Human eye

    Thermography

    Stage 1 - Superficial ulcer

    • Open sore involving only the skin

    • No involvement of deeper tissues

    • Often painless due to neuropathy

    Human eye

    Thermography

    Stage 2 - Deep ulcer

    • Ulcer extends into deeper tissues (tendons, ligaments, or muscle)

    • No bone infection yet

    • Increased risk of infection

    Human eye

    Thermography

    Stage 3 - Deep ulcer with infection

    • Ulcer involves deep tissues with abscess, osteomyelitis, or joint infection

    • Significant inflammation and possible drainage

    • Serious limb-threatening condition

    Human eye

    Thermography

    Stage 4 - Localized gangrene

    Often requires surgical intervention or amputation

    Human eye

    Thermography

    Stage 5 - Extensive gangrene

    Often requires surgical intervention or amputation

    Human eye

    Thermography

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    Rytis Zajanckauskas, MD

    CEO, Feetsee

    A Letter from the CEO

    Diabetes is a significant health challenge affecting over 1 in 10 Americans, with 88 million adults at risk of developing the disease. Among those diagnosed, 9.6 million suffer from peripheral neuropathy, a major risk factor for foot ulceration.

    Each year, 1.6 million patients with diabetes in the U.S. experience diabetic foot ulcers (DFUs), the leading cause of diabetes-related amputations. Alarmingly, 154,000 diabetes-related amputations occur annually in the U.S., with a limb being amputated every 30 seconds somewhere in the world as a consequence of diabetes.

    At Feetsee, our mission is to combat these devastating statistics. Our innovative medical device and algorithm are designed to provide early detection and timely intervention, ultimately reducing the incidence of severe complications and amputations. Thank you for choosing Feetsee as your partner in foot health.

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    (1) Yao, Yuanying, Chen, Lei, Qian, Yu, Age Characteristics of Patients With Type 2 Diabetic Foot Ulcers and Predictive Risk Factors for Lower Limb Amputation: A Population-Based Retrospective Study, Journal of Diabetes Research, 2024, 2380337, 8 pages, 2024. https://doi.org/10.1155/jdr/2380337

    (2) Mariam TG, Alemayehu A, Tesfaye E, Mequannt W, Temesgen K, Yetwale F, Limenih MA. Prevalence of Diabetic Foot Ulcer and Associated Factors among Adult Diabetic Patients Who Attend the Diabetic Follow-Up Clinic at the University of Gondar Referral Hospital, North West Ethiopia, 2016: Institutional-Based Cross-Sectional Study. https://doi.org/10.1155/2017/2879249

    (3) IWGDF 2023 Peripheral Artery Disease (PAD) Guideline, https://iwgdfguidelines.org/wp-content/uploads/2023/07/IWGDF-Guidelines-2023.pdf

    (4) Tang WH, Zhao YN, Cheng ZX, Xu JX, Zhang Y, Liu XM. Risk factors for diabetic foot ulcers: A systematic review and meta-analysis. Vascular. 2024 Jun;32(3):661-669. doi: 10.1177/17085381231154805.

    (5)Jupiter DC, Thorud JC, Buckley CJ, Shibuya N. The impact of foot ulceration and amputation on mortality in diabetic patients. I: From ulceration to death, a systematic review. International Wound Journal. 2016 Oct;13(5):892–903. doi: 10.1111/iwj.12404. PMCID: PMC7950078.

    (6)Golledge J, Fernando ME, Alahakoon C, et al. Efficacy of at-home monitoring of foot temperature for risk reduction of diabetes-related foot ulcer: a meta-analysis. Diabetes/Metabolism Research and Reviews. 2022.

    (8) Camarena, M. F., Izquierdo-Renau, M., Julian-Rochina, Í., Arrébola, M., & Miralles, M. (2024). Update on the use of infrared thermography in the early detection of diabetic foot complications: A bibliographic review. Sensors, 24(1), 252. https://doi.org/10.3390/s24010252

    (9) Lim, J. Z. M., Ng, N. S., & Thomas, C. (2017). Prevention and treatment of diabetic foot ulcers. Journal of the Royal Society of Medicine, 110(3), 104-109. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5349377/

    (10)Armstrong DG, Tan T-W, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578. PMID: 37395769.

    (11) Bus, S. A., & van Netten, J. J. (2016). A shift in priority in diabetic foot care and research: 75% of foot ulcers are preventable. Diabetes/Metabolism Research and Reviews, 32(Suppl 1), 195-200. https://pubmed.ncbi.nlm.nih.gov/26452160/

    (12) Wound Care Education Institute. (2024, October 3). Diabetic foot ulcer stages. WCEI

    https://www.wcei.net/wound-care/diabetic-foot-wounds/diabetic-foot-ulcer-stages