Great Debates and Updates in Diabetic Foot: Insights on Remote Patient Monitoring

At the recent Great Debates and Updates in Diabetic Foot meeting in Dallas, TX, experts faced off in lively and engaging debates and panels on the latest research and clinical pearls. In particular, Bijan Najafi, PhD, took on the topic of remote patient monitoring (RPM) by beginning with a unique perspective. How does this concept fit into the future of health care? For more of his insights on the decentralization of health care and evidence-based insights on remote temperature monitoring, click here for additional insights from the conference. Dr. Najafi noted that since individuals who live more than 50 miles from an experienced hospital have a higher likelihood of amputation,¹ options that shift the care model away from the hospital may carry significant value.

Where Can Remote Patient Monitoring Have an Impact?

As opposed to periodic traditional visits, or periodic home monitoring, what value is there in continuous remote patient monitoring methods? Dr. Najafi shared publications that advocate for continuous monitoring, specifically when thinking about shear forces.^2,3 Although shear is hard to measure, he reminded the audience that a change in temperature resulting from that stress could be a valuable indicator.

Although it is often a focus for many clinicians, Yavuz and team in 2015 pointed out that plantar pressure does not represent the entire picture.⁴ Instead, shear must be part of the consideration. Dr. Najafi summarized that there must be additional metrics to complete the equation. An interesting example of this was the focus of an article by Rahemi and colleagues in 2017.⁵ These authors found significant differences in temperature due to shear forces from improperly tied shoelaces.⁵ Additionally, Dr. Najafi shared a study by Wrobel and team that presented shear reduction insoles, with a floating distal foot area.⁶

Dr. Najafi stressed the importance of empower patients to be a part of the process in any type of remote monitoring. One area in which he feels this is well characterized is the effort one makes to offload a limb. He shared that although total contact casting is considered a gold standard, it does not seem to be a community standard. Looking at all of the options for offloading, including removable and irremovable methods, they all have challenges. However, he said that he believes that a “smart” removable cast boot, along with appropriate empowerment of the patient may be a viable solution.

A recently published randomized controlled trial that Dr. Najafi coauthored looked at patient perceptions of a mobile app associated with an offloading boot that provided behavioral feedback, positive reinforcement for patients, and alerts regarding nonadherence.⁷ The authors stated that their findings may assist in future development of patient educational outreach and offloading design.⁷ Dr. Najafi commented that such apps may present an opportunity for “gamification” and simplification of the process. He added that these systems can also provide objective data to clinicians like adherence and time of use. Another recent pilot validation test reinforced the potential of a smart boot with a companion app.⁸

Dr. Najafi then shared early results of a current clinical trial on the effectiveness of patient engagement using smart offloading.⁹ He said 114 patients are currently recruited into the study and 106 have completed the trial thus far. Patients are in three groups: one using a smart removable cast boot walker, one using a traditional removable cast boot walker (with counseling on the importance of following treatment instructions), and one using an irremovable device. As far as time to heal in days, the early results suggest, said Dr. Najafi, that the smart device is performing best, followed by the irremovable device and then the traditional boot with instructions.⁹

Leveraging RPM for Personalized Care

Dr. Najafi then addressed how providers can use data from remote patient monitoring to create targeted, personalized care plans for patients. He advocated for evaluating this concept as part of a multi-point plot, including metrics like wound characteristics (baseline size, wound score [Wagner], wound age, HbA1c level), motor performance (slow walking, poor balance, exhaustion, slowness, steps), and patient-reported outcomes (body mass index [BMI], age, cognition). He then shared some promising case observations that suggest that baseline wound size, wound age, exhaustion/frailty, HbA1c, cognition, BMI, and steps are valuable predictors of healing potential.

Gamification of Exercise

Exercise as a form of medicine is not a new concept, Dr. Najafi explained. Home-based foot and ankle exercises have potential to contribute to the improvement of flexibility, strength, balance, and gait. Therefore, finding ways to engage patients in these activities, in a way where clinicians can remotely monitor results, is promising. Two studies further explored this “exergaming,” using sensors on the foot to gamify ankle exercises, proprioception, resistive exercise, and more.^10,11 Another study placed this type of exercise game in dialysis centers.¹² The authors found that this training could improve balance and speed of gait in an at-risk population and could increase adherence and reduce associated burdens with completing these tasks.

In Summary: Looking Towards the Future

Dr. Najafi shared several concepts of interest moving forward when it comes to remote patient monitoring. For instance, smart dressings, involving biosensors on the wound dressings, could address gaps created by telemedicine for clinical information.¹² Smart digital assistants and apps may continue to evolve, especially when engaging patients in wound imaging.¹³ Overall, Dr. Najafi stressed that the alarmingly high rates of DFUs and recurrence require a change in approach. Advances in health technology can enable monitoring of risk factors remotely and simultaneously engage patients in the “health ecosystem.” Finally, he reminded the audience that RPM can be a tool to empower patients to have self-awareness of risk factors and perform self-care. He concluded that initial evidence for RPM confirms its viability in identifying risk factors and paves the way for a more holistic view on limb preservation.

Editor’s Note: For more coverage and insights from the dynamic lectures and expert faculty at the 2023 Great Debates and Updates in Diabetic Foot meeting, click here.

References

1. Barshes NR, Uribe-Gomez A, Sharath SE, Mills JL Sr, Rogers SO Jr. Leg amputations among Texans remote from experienced surgical care. J Surg Res. 2020;250:232-238.
2. Lazzarini PA, Crews RT, van Netten JJ, Bus SA, Fernando ME, Chadwick PJ, Najafi B. Measuring plantar tissue stress in people with diabetic peripheral neuropathy: a critical concept in diabetic foot management. J Diabetes Sci Technol. 2019 Sep;13(5):869-880.
3. Najafi B, Grewal GS, Bharara M, Menzies R, Talal TK, Armstrong DG. Can’t stand the pressure: the association between unprotected standing, walking, and wound healing in people with diabetes. J Diabetes Sci Technol. 2017;11(4):657-667. doi:10.1177/1932296816662959
4. Yavuz M, Master H, Garrett A, Lavery LA, Adams LS. Peak plantar shear and pressure and foot ulcer locations: a call to revisit ulceration pathomechanics. Diabetes Care. 2015 Nov;38(11):e184-5.
5. Rahemi H, Armstrong DG, Enriquez A, Owl J, Talal TK, Najafi B. Lace up for healthy feet: the impact of shoe closure on plantar stress response. J Diabetes Sci Technol. 2017;11(4):678-684. doi:10.1177/1932296817703669
6. Wrobel JS, Ammanath P, Le T, et al. A novel shear reduction insole effect on the thermal response to walking stress, balance, and gait. J Diabetes Sci Technol. 2014;8(6):1151-1156. doi:10.1177/1932296814546528
7. Finco MG, Cay G, Lee M, Garcia J, Salazar E, Tan TW, Armstrong DG, Najafi B. Taking a load off: user perceptions of smart offloading walkers for diabetic foot ulcers using the technology acceptance model. Sensors (Basel). 2023;23(5):2768.
8. Park C, Mishra R, Vigano D, Macagno M, Rossotti S, D’Huyvetter K, Garcia J, Armstrong DG, Najafi B. Smart offloading boot system for remote patient monitoring: toward adherence reinforcement and proper physical activity prescription for diabetic foot ulcer patients. J Diabetes Sci Technol. 2023;17(1):42-51.
9. Smart boot to measure offloading adherence. NCT04460573. Available at https://clinicaltrials.gov/study/NCT04460573?term=NCT04460573&rank=1. Accessed December 1, 2023.
10. Rahemi H, Chung J, Hinko V, Hoeglinger S, Martinek WA, Montero-Baker M, Mills JL, Najafi B. Pilot study evaluating the efficacy of exergaming for the prevention of deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2018;6(2):146-153.
11. Zhou H, Al-Ali F, Kang GE, Hamad AI, Ibrahim RA, Talal TK, Najafi B. Application of wearables to facilitate virtually supervised intradialytic exercise for reducing depression symptoms. Sensors (Basel). 2020;20(6):1571.
12. Finco MG, Najafi B, Zhou H, Hamad A, Ibrahim R, Al-Ali F. Game-based intradialytic non-weight-bearing exercise training on gait speed and balance in older adults with diabetes: a single-blind randomized controlled trial. Sci Rep. 2023;13:14425.
13. Ashley BK, Brown MS, Park Y, Kuan S, Koh A. Skin-inspired, open mesh electrochemical sensors for lactate and oxygen monitoring. Biosensors Bioelectronics. 2019;132:343-351.
14. Ploderer B, Brown R, Seng LSD, Lazzarini PA, van Netten JJ. Promoting self-care of diabetic foot ulcers through a mobile phone app: user-centered design and evaluation. JMIR Diabetes. 2018;3(4):e10105.