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Technology in Medicine Adam L. Isaac, DPM Complex Foot Wound Clinic Kaiser Permanente Mid-Atlantic States Adam L. Isaac, DPM Complex Foot Wound Clinic Kaiser Permanente Mid-Atlantic States

#Podiatric Technology in Medicine @APMA #YPI2017 Adam L. Isaac, DPM Complex Foot Wound Clinic Kaiser Permanente Mid-Atlantic States

Technology in medicine The past, the present, and the future Impact on day-to-day practice Podiatric Medicine & Technology Have we become too dependent?

The Ether Dome First public surgery using anesthetic (ether), in 1846. http://www.massgeneral.org

The smart operating room Sacred Heart Hospital, Eau Claire, Wisconsin https://mcdmag.com

The past Amputation in the 18 th century by Christopher Fisher @DrLindseyFitz

The Past (late 20 th century) Paper Charts Handwritten orders and instructions Pagers (and oversized cell phones!) Unencrypted lists and messages containing protected health information (PHI) HIPAA, who?

The Present Electronic medical records (EMR) Secure (HIPAA-compliant) text and video messages between providers Video and telephone appointments Direct messages from patients Data mining

Technology in medicine The past, the present, and the future Impact on day-to-day practice Podiatric Medicine & Technology Have we become too dependent?

Electronic Medical Record (EMR) All patient records in one place Easy access for multiple providers Integrated surgical and clinic schedules e-consult (instant referral system) e-prescriptions

Snap Shot

e-consult

e-prescribe

Remote, remote access

Mobile EMR

Secure communications Cortext (Imprivata) Pager replacement Direct messaging between physicians and other healthcare providers HIPAA compliant Works with smartphones, tablets, and desktops Know when a message is read, and who is available Decrease distraction and focus care

Secure communications

Technology in medicine The past, the present, and the future Impact on day-to-day practice Podiatric Medicine & Technology Have we become too dependent?

Diabetic foot ulcer Up to 25% of people with diabetes will develop a foot ulcer at some point during their lifetime 3 Half will become infected and require hospitalization 4 One in five will go on to amputation 4 People with a history of a diabetic foot ulcer have a 40% greater ten-year mortality rate than diabetic patients without a foot ulcer 5 3. Singh N, Armstrong DG, Lipsky BA. Preventing Foot Ulcers in Patients With Diabetes. JAMA. 2005;293(2):217-228. 4. Lavery LA, Armstrong DG, Wunderlich RP, Mohler MJ, Wendel CS, Lipsky BA. Risk factors for foot infections in individuals with diabetes. Diabetes Care. 2006 Jun;29(6):1288-93. 5. Iversen MM, Tell GS, Riise T, Hanestad BR, Østbye T, Graue M, Midthjell K. History of foot ulcer increases mortality among individuals with diabetes: ten-year follow-up of the Nord-Trøndelag Health Study, Norway. Diabetes Care. 2009Dec;32(12):2193-9.

Amputation Of the people who undergo a major amputation, 20-50% will have the contralateral limb amputated in 1-3 years Greater than 50% will require an amputation in 5 years Van Gils, CARL C., et al. "Amputation prevention by vascular surgery and podiatry collaboration in high-risk diabetic and nondiabetic patients. The Operation Desert Foot experience." Diabetes Care 22.5 (1999): 678-683

Amputation Mortality rates following an amputation 3 13% to 40% at 1 year 35% to 65% at 3 years 39% to 80% at 5 years This is worse than for most malignancies 7,8 3. Singh N, Armstrong DG, Lipsky BA. Preventing Foot Ulcers in Patients With Diabetes. JAMA. 2005;293(2):217-228. 7. Armstrong DG, Wrobel J, Robbins JM. "Guest Editorial: Are diabetes-related wounds and amputations worse than cancer." Int Wound J4.4 (2007): 286-87. 8. Armstrong DG, Mills JL. Toward a change in syntax in diabetic foot care: prevention equals remission. J AmPodiatr Med Assoc. 2013Mar-Apr;103(2):161-2.

Recurrence Between 30-40% of patients develop at least one new foot ulcer in the first year after healing 10-15 By year 3, about 60% of patients have reulcerated Re-ulceration decreases the farther you are from closure date Goal is to shift as many patients as possible to the right, past one year

Remission: Now What?

Infrared Dermal Thermometry for the High-risk Diabetic Foot (1997) 143 consecutive patients Neuropathy without acute pathology (78) Charcot arthropathy (21) Active DFU (44) Skin temperatures from 6 corresponding sites on the plantar aspect of both feet Differences in skin temperature between corresponding sites on contralateral limbs were noted in the Charcot and active DFU groups; no difference was noted in the asymptomatic sensory neuropathy group Temperature asymmetry may be useful for identifying patients at risk for developing DFU Armstrong DG, Lavery LA, Liswood PJ, Todd WF, Tredwell JA. Infrared dermal thermometry for the high-risk diabetic foot. Phys Ther. 1997 Feb;77(2):169-75.

Infrared Dermal Thermometry for the High-risk Diabetic Foot (1997) Armstrong DG, Lavery LA, Liswood PJ, Todd WF, Tredwell JA. Infrared dermal thermometry for the high-risk diabetic foot. Phys Ther. 1997 Feb;77(2):169-75.

Back to the Future? Armstrong DG, Lavery LA, Liswood PJ, Todd WF, Tredwell JA. Infrared dermal thermometry for the high-risk diabetic foot. Phys Ther. 1997 Feb;77(2):169-75.

Skin Temperature Monitoring Reduces the Risk for Diabetic Foot Ulceration in High-risk Patients (2007) 225 high-risk patients followed for 18 months (RCT) Standard therapy Dermal thermometry Both groups received therapeutic footwear, diabetic foot education, regular foot care, and performed daily foot inspection Dermal Thermometry Group subjects used an infrared skin thermometer to measure temperatures on six corresponding sites, on each foot, twice daily Temperature differences > 4 F between corresponding sites on the contralateral foot triggered patients to contact the study nurse, reduce activity until temperatures normalized 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.

Skin Temperature Monitoring Reduces the Risk for Diabetic Foot Ulceration in High-risk Patients (2007) 8.4% (19) ulcerated over the 18-month follow-up period Standard Therapy Group: 12.2% (14) Dermal Thermometry Group: 4.7% (5) Subjects were one third as likely to ulcerate in the dermal thermometry group compared with standard therapy group 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.

Challenges of Home Monitoring

Podimetrics Remote Temperature Monitoring System

Podimetrics Remote Temperature Monitoring System Automated, easy-to-use, telemedicine monitoring solution designed to address the shortcomings of existing thermometric devices Intended to be used to help identify patients with persistent foot inflammation who may benefit from early, non-invasive offloading therapies The system consists of a floor mat, an analytics cloud, and a clinical decision support web application

Podimetrics Remote Temperature Monitoring System

Podimetrics Remote Temperature Monitoring System Podimetrics Mat is a daily-use, wireless, in-home, FDA-cleared medical device with an array of thermometric sensors under a water-resistant cover It is designed to be used directly out-of-the-box without configuration or setup by the patient The device remains in standby until the patient is ready to use it, which is accomplished by stepping on the Mat and remaining stationary for approximately 20 seconds During this time, the Mat records a high-resolution thermometric scan, or thermogram, of the patient's feet

In-Home Assessment of a Smart Foot Mat for the Prevention of Diabetic Foot Ulcers (Frykberg, et al.) 129 high risk patient across 7 sites Inclusion criteria History of plantar DFU, and no current or active plantar foot pathology (i.e. Charcot) Enrollees were provided a Podimetrics Mat and instructed to use it daily for 34 consecutive weeks 53 plantar DFU occurred in 37 patients over the course of 34 weeks Distribution of temperature asymmetry was found to strongly differentiate the scans of those who developed DFU from those who did not

In-Home Assessment of a Smart Foot Mat for the Prevention of Diabetic Foot Ulcers (Frykberg, et al.) Subject A did not reulcerate Subject B formed ulcer 4 weeks later

In-Home Assessment of a Smart Foot Mat for the Prevention of Diabetic Foot Ulcers (Frykberg, et al.) 3 months after healing One month prior to reulceration Following 5 weeks treatment

Evaluation of a Remote Temperature Monitoring System for the Prevention of Diabetic Foot Ulcers IRB Number: MA-16-134 Principal Investigator: Adam L. Isaac, DPM Sub-investigator: Amey Kulkarni, MD Co-investigator: Jonathan Bloom, MD Co-investigator/Project Manager: Natalie Reid, MPH, MBA Primary outcome of interest: To evaluate the use of Podimetrics Remote Temperature Monitoring System to reduce the occurrence and recurrence of diabetic foot ulcers and reduce total health care utilization for diabetic patients with a foot ulcer that have healed in the past two years

Evaluation of a Remote Temperature Monitoring System for the Prevention of Diabetic Foot Ulcers Secondary outcome of interest: To observe ulcer-free survival over one year Other outcomes of interest: Total ulcer days (number of days a participant has an open ulcer or wound under treatment) Ulcer Grade based on the University of Texas Wound Classification System Total health care utilization, including hospitalizations, emergency department visits, in-person or office visits Number of amputations Number of telephone encounters Number of secure messages

Evaluation of a Remote Temperature Monitoring System for the Prevention of Diabetic Foot Ulcers Inclusion criteria Male or female 18 years of age with a diagnosis of diabetes (Type I or II) History of healed plantar Diabetic Foot Ulcer(s) or healed amputation(s) within the last 24 months Ability to provide informed consent Adequate lower extremity blood supply

Evaluation of a Remote Temperature Monitoring System for the Prevention of Diabetic Foot Ulcers Exclusion criteria Patients with ulcers or open lesions Active Charcot Active foot infection or gangrene Any mental health disorder, psychiatric disorder, or alcohol or drug abuse history such that, in the opinion of the investigator, the patient is unreliable as a study participant

Evaluation of a Remote Temperature Monitoring System for the Prevention of Diabetic Foot Ulcers Exclusion criteria (Cont.) History of amputation more proximal than a transmetatarsal amputation in either foot. Inability to ambulate without the assistance of a wheelchair, walker, or crutches Any travel plans expected to result in an interruption of Podimetrics Mat use for greater than two consecutive weeks [Note: OK for participant to take device with them and use during travel] Unable to return to Physician Investigator for study visits and study related foot care for the duration of the study to return to Physician Investigator for study visits and study related foot care for the duration of the study

Technology in medicine The past, the present, and the future Impact on day-to-day practice Podiatric Medicine & Technology Have we become too dependent?

References 1. International Diabetes Federation. IDFDiabetes Atlas, 7th edition. Brussels, Belgium: International Diabetes Federation, 2015. http://www.idf.org/diabetesatlas 2. Centers for Disease Control and Prevention. Diabetes Report Card 2014. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2015. 3. Singh N, Armstrong DG, Lipsky BA. Preventing Foot Ulcers in Patients With Diabetes. JAMA. 2005;293(2):217-228. 4. Lavery LA, Armstrong DG, Wunderlich RP, Mohler MJ, Wendel CS, Lipsky BA. Risk factors forfootinfections in individuals with diabetes. Diabetes Care. 2006 Jun;29(6):1288-93. 5. Iversen MM, Tell GS, Riise T, Hanestad BR, Østbye T, Graue M, Midthjell K. History of foot ulcer increases mortality among individuals with diabetes: ten-year follow-up of the Nord-Trøndelag Health Study, Norway. Diabetes Care. 2009 Dec;32(12):2193-9. 6. Van Gils, CARL C., et al. "Amputation prevention by vascular surgery and podiatry collaboration in high-risk diabetic and nondiabetic patients. The Operation Desert Foot experience." Diabetes Care 22.5 (1999): 678-683. 7. Armstrong DG,Wrobel J, Robbins JM. "Guest Editorial: Are diabetes-related wounds and amputations worse than cancer." Int Wound J4.4 (2007): 286-87. 8. Armstrong DG, Mills JL. Toward a change in syntax in diabetic foot care: prevention equals remission. J Am Podiatr Med Assoc. 2013 Mar-Apr;103(2):161-2. 9. Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, Lavery LA, Lemaster JW, Mills JL Sr, Mueller MJ, Sheehan P, Wukich DK; American Diabetes Association; American Association of Clinical Endocrinologists. Comprehensive foot examination and risk assessment: a report of the task force of the foot care interest group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Diabetes Care. 2008 Aug;31(8):1679-85 10. Morbach S, Furchert H, Gröblinghoff U, Hoffmeier H, Kersten K, Klauke GT, Klemp U, Roden T, Icks A, Haastert B, Rümenapf G, Abbas ZG, Bharara M, Armstrong DG. Long-term prognosis of diabetic foot patients and their limbs: amputation and death over the course of a decade. Diabetes Care. 2012 Oct;35(10):2021-7. 11. Apelqvist J, Larsson J, Agardh CD. Long-term prognosis fordiabetic patients with footulcers. J Intern Med. 1993 Jun;233(6):485-91. 12. Pound N, Chipchase S, Treece K, Game F, Jeffcoate W. Ulcer-free survival following management offoot ulcers in diabetes. Diabet Med. 2005 Oct;22(10):1306-9. 13. Dubský M, Jirkovská A, Bem R, Fejfarová V, Skibová J, Schaper NC, Lipsky BA. Risk factors for recurrence of diabetic foot ulcers: prospective follow-up analysis in the Eurodiale subgroup. Int Wound J. 2013 Oct;10(5):555-61. 14. Ulbrecht JS, Hurley T, Mauger DT, Cavanagh PR. Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial. Diabetes Care. 2014 Jul;37(7):1982-9. 15. Waaijman R, de Haart M, Arts ML, Wever D, Verlouw AJ, Nollet F, Bus SA. Risk factors for plantar foot ulcer recurrence in neuropathic diabetic patients. Diabetes Care. 2014 Jun;37(6):1697-705. 16. Armstrong DG,Lavery LA, Liswood PJ, Todd WF, Tredwell JA. Infrared dermal thermometry forthe high-risk diabetic foot. Phys Ther. 1997 Feb;77(2):169-75. 17. 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.

Thank you for your attention! Adam.L.Isaac@kp.org http://kp.org/doctor/adamisaac