SOP_TMD_5_26_2022.pdf

Topic: Temperature Monitoring Devices (TMD) for Feet

Purpose: This document details circumstances for appropriate provision of

Temperature Monitoring Devices (TMD) for feet in the management of patients at risk of inflammatory foot conditions such as diabetic foot ulcers (DFU) for Veterans, with guidance for staff.

Background: Use of once-daily thermometry as a modality for the prevention of DFU has been referred to as Temperature-Guided Avoidance Therapy. The practice may be summarized as the temporary use of off-loading strategies (e.g. decreased ambulation or removable cast walker placement) during periods of persistent, localized elevations in plantar skin temperature.

Once-daily temperature-Guided Avoidance Therapy has been investigated in three

NIHfunded randomized controlled trials,1-3 one of which additionally supported by VA

HSR&D Merit Award 20-059.3 Enrolled participants have been pooled from patients in either Category 2 (neuropathy and structural foot deformity) or Category 3 (history of foot ulcer or partial foot amputation) of the International Diabetic Foot Risk Classification

System.8 Across the three trials, use of thermometry coupled with early offloading resulted in a 70.0% reduction in occurrence of ulceration in this high risk group.1-3 As a result, daily measurement of foot temperatures in high risk groups has been incorporated into three clinical practice guidelines: the American College of Foot and

Ankle Surgeons,4 the International Working Group on the Diabetic Foot,5 and the

Wound Healing Society.6

Despite these data and inclusion into clinical practice guidelines, temperature monitoring remains uncommon in practice, largely due to challenges in adherence when using hand-held temperature probes.7 TMDs have been developed to address these concerns, incorporating daily thermometry into a passive smart mat for the home. A multicenter trial of one such device published in 2017 with 129 participants (including 58 veterans) suggests the mat may detect as many as 97% of plantar non-traumatic DFU.

Mean adherence to daily use across the population over the 34-week participation period was 5.4 days/week.7

TMDs are considered for patients at risk of inflammatory foot conditions such as diabetic foot ulcers. The device is an in-home telemedicine mat that enables remote temperature asymmetry monitoring of the plantar surfaces of a patient's feet to detect areas of inflammation. A 2017 study in Diabetes Care reported detection of 97% of DFU approximately five weeks prior to clinical presentation using the one such device

(additional details in Clinical Background).7

Clinical Guidance: TMDs are intended to be used by a patient in conjunction with a healthcare professional or caretaker for daily monitoring of the temperature over the soles of the feet for signs of inflammation. It will provide information indicating when the patient and healthcare provider should communicate for further evaluation and treatment regarding any persistent localized inflammation observed on the feet via the electronic sensing system and remote visualization of its data. TMDs are intended to be used under the direction of a healthcare professional as an adjunct to, and not in replacement of, self-examination and periodic foot care and examination conducted by a healthcare professional and does not diagnose any specific disease state.

As of July 2017, use of thermometry for prevention of DFU is well-supported by three randomized controlled trials1-3 and is recommended by three separate clinical practice guidelines.4-6

Criteria for issuance:

Veterans suitable for TMDs are those who are at risk for inflammatory conditions of the foot, e.g. DFU or Acute Charcot. For Veterans at-risk of foot ulceration, suitable

Veterans include those with peripheral neuropathy and a history of foot ulcer, lowerextremity amputation, or Charcot foot, particularly immediately following a wound closure or partial foot amputation (See table 1). Use of TMDs is contraindicated for a wounded plantar foot. Patients with a wound on the plantar surface on one foot can continue to use the TMDs to monitor for inflammation to an unwounded foot. TMD’s may also be used for patients with a major lower extremity amputation (Symes ankle disarticulation or more proximal) to monitor the contralateral foot. Patients may use the device sitting or standing but sitting is preferred to reduce the risk of falls. TMDs will be automatically renewed at the end of 12 months if the patient uses at least 1x/week on average and they have used in the last month. If a patient does not meet this renewal criteria the vendor will notify the provider who can decide on if a renewal is warranted or not. Value would be measured by patient adherence and early detection.

Table 1: Patient Selection by Risk Category

Pave

Level/Risk

Category

Characteristics Guidance

3 Peripheral neuropathy, and history of lower extremity amputation and/or Charcot Foot

Eligible

3 History of Type 1 or 2 Diabetes and history of Foot Ulcer Eligible

3 Foot Risk score 3 without history of ulcer or amputation Not

Eligible

2 Peripheral neuropathy with a minor foot deformity Not

Eligible

1 No peripheral neuropathy Not

Eligible

0 No peripheral neuropathy Not

Eligible

When a TMD is prescribed, the following procedures and protocols are suggested:

● Device Ordering and Enrollment: A Clinical Provider will enter an

Enrollment Note using the national Remote Temperature Monitoring

Templates once an eligible veteran has been identified and selected.

The National FAST Ordering Team will track signed Enrollment Notes and enter ROES orders on behalf of providers. Once a TMD has been shipped out from the DLC an addendum will be added to the originally signed Enrollment Note to notify the ordering provider.

● Patient Training: The Clinical Provider, their trained designee, or an authorized vendor representative may then train the patient in appropriate use and collect the first scan. Please refer to the manufactures instructions for use document accompanying each device and instructions from a company representative for appropriate training guidance.

● Daily Home Use: Once trained, the patient will be instructed to use the device daily.

● Suggested Low Adherence Protocol: Some devices generate a report detailing patients who have not used the device for more than seven consecutive days.

This report is delivered to designated clinical resource or a trained designee.

Patients should be called to re-engage within the week. If a patient demonstrates inconsistent adherence, the provider should consider this in the decision to reorder at the end of 12 months. A patient who does not use the device regularly will not see the value of early detection.

● Suggested Asymmetry Protocol: The following Asymmetry Protocol derives from the work of Lavery, Armstrong, and Frykberg, and is being used in VA Podiatry clinics as of July 2017. However, this is but one example of how to monitor patients for inflammation. The protocol is appropriate for patients who have not undergone amputation of the entire plantar surface of either foot (Syme amputation or more distal) and appropriate for patients with partial foot amputations at any level

(syme, transmetatarsal, digit, etc.) Other protocols relying on a single foot may be used for patients with a major lower extremity amputation

(Symes ankle disarticulation or more proximal).

The protocol detailed here uses plantar temperature asymmetry, which compares the temperature between six contralaterally matched locations on the plantar surfaces of the feet: the hallux, the 1st, 3rd, and 5th metatarsal heads, the arch, and the heel. If a patient exceeds the preset threshold for an Asymmetry Episode

(defined below), the following procedures are followed:

○ Initiation: A patient triggers an alert after two consecutive days of asymmetry exceeding 2.22 degrees C at the same location on the foot.4-7

An Asymmetry report will be generated by Podimetrics and the designated clinical resource will be notified.

○ Initial Response: The Designee will contact and notify the veteran that the

Podimetrics RTM Smart Mat has detected signs of foot inflammation and reassure the patient that there are simple non-invasive therapies that may reduce the patient’s risk of complications. The Designee will collect a subjective history for further triage. The Designee will ask the patient to inspect the foot or feet, ideally with the assistance of a caregiver, looking for the following abnormalities:

- discolored, ingrown, or elongated nails

- skin dryness, erythema or other discoloration

- skin defect or fissure

- interdigital maceration

- drainage or edema

- pre-ulcerative lesions such as callus and blister

- plantar or dorsal wound

In addition, the Designee will inquire if the patient has experienced any acute signs-of-infection (e.g. fever, chills, nausea, vomiting, etc.), has changed activity level, and has always been wearing prescribed footwear daily, including accommodative insoles.

Finally, the Designee will instruct the patient to:

● walk 50% of their baseline step-count over the next two weeks and be very mindful of any changes to the foot or feet

● be diligent in completing daily foot checks, with the assistance of a caregiver if possible

● notify the clinic staff if they observe any changes in the foot or feet

(e.g. blister, callus, bleeding, redness, swelling)

● avoid activities with prolonged standing or walking, to the extent possible

● wear most protective shoes throughout the day, including indoors

● inspect footwear and accommodative insoles and replace as necessary

● consider using an offloading device, such as a removable walking boot or pressure relief shoes, if the patient has received one previously.

○ Follow-up: If a patient experiences two scans exceeding temperature asymmetry threshold during the next four weeks (do not need to be consecutive days) OR if a patient reports a clinically significant finding, an updated Report is generated by the TMD vendor, and the Designee is notified via an Escalation Alert. These Escalation Alerts should be documented in the medical record using the Escalation Alert note title from the national Remote Temperature Monitoring Templates. The local provider would then make a clinical decision about the next course of action needed.

○ Resolution: The patient will remain in Asymmetry Episode until achieving two-four weeks without a scan exceeding temperature asymmetry at all six locations. At this point the Asymmetry Episode has resolved and the patient may return to their recommended routine, including but not limited to their baseline activity level, daily self-examinations, and use of the

Podimetrics Mat.

The prescribing clinician must ensure that the following is conducted and documented in the Veteran’s medical record:

● Enrollment Note completed which summarizes the education and training provided to the patient and their consent to enroll in the program

After training the Veteran must demonstrate the following:

● Ability to independently and safely operate the TMD or have a caregiver who can,

● Ability to utilize the device following instructions,

● Ability to clean, care for, maintain and troubleshoot the device,

● Know whom to contact if the device is not operating properly, Clinicians must ensure appropriate follow up is provided based on the Veteran’s individual medical needs. Follow-up appointment(s) must be conducted and documented in the Veterans electronic medical record.

This follow-up may occur in the clinic, via Telehealth, via phone call, VA secure messaging etc. Click here for a useful guidance document.

This document was created by the National Podiatry Program Office in collaboration with National Prosthetic and Sensory Aids Service, the Office of Connected Care, and the Diffusion of Excellence Program.

Resources:

Documentation & Escalation Pathway Prevention of Ulcers & Amputations

Temperature Monitoring Templates

Temperature Monitoring Install Guide

Appendix:

DEFINITIONS:

a) Temperature Monitoring Mat: A telemedicine floor mat with temperature sensors that allows for daily collection of plantar temperature measurements in accordance with existing practice guidelines.

b) Low Adherence Threshold: The minimum adherence goal set for each patient where, if usage drops below it, a call will be attempted to re-encourage daily usage. The default minimum daily adherence goal is three days/week on average.

c) Asymmetry Protocol: The clinical procedure followed (defined below) if/when a patient is determined to have an active temperature asymmetry

d) Asymmetry Episode: The period of time defined by the Asymmetry Protocol where the patient has been determined to have an active temperature asymmetry.

https://vaots.blackboard.com/bbcswebdav/xid-1229645_1 https://vaots.blackboard.com/bbcswebdav/xid-1229645_1 https://vaots.blackboard.com/bbcswebdav/xid-1229645_1 https://vaots.blackboard.com/bbcswebdav/xid-1229645_1 https://prod-dm.s3.us-gov-west-1.amazonaws.com/practice_resources/attachments/000/001/078/original/Using_the_Remote_Temperature_Monitoring_Templates_%28CPRS%29_March_2022.pptx?X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=ASIAR2ERFC2NGKXLV4MX%2F20220526%2Fus-gov-west-1%2Fs3%2Faws4_request&X-Amz-Date=20220526T140722Z&X-Amz-Expires=84000&X-Amz-Security-Token=FwoDYXdzEKT%2F%2F%2F%2F%2F%2F%2F%2F%2F%2FwEaDIIu78nSs3W1ACS4uCKDBFkQ5jiIZ7Bp2Yk8A%2F2SIQfTshZlUjUImS9C4uteCnb4jCiSV5mHLezeRTUJilzUtym8O6V%2Ff4b6MDqKr2H%2Fl%2FBBBSornxUH5xrv7dpaMEvbD2Bop4%2BVI3G66PBwQXR00E7B6sH1iKGb5IP4DHuxlkUCdGPhK3RMFE9UmaJRpq1z7lwdSpu20uuFfI6W2VIgqUUAh1hn%2FEqgwPMAL07uVXbW4TW%2Bi9vGGkJxRjQPm0r%2BbPkj4n5lPf7yK1mfuFyokBxrov3Uk1c0J6RDO93wOWo8tZz90KR%2BYLxOw9S8rMEvqJxVodYzNEmyzZI%2B9nDi7k%2Frz7K5FWdV7hwAxZbplXJ7di3XetCCmy4zxjTTg%2FFTP4SAcuiKzV%2BcF9cxt2Vc%2BpnAt60pzhG4DSTg8PlWFrgQqKvaUjoGUOikqQaKIsVB%2BuDUmvsgVdFy41UuiBYuyWapUTd%2BbuZQ29cWwGAmTSfsFvkOKSdKKrzffzch43sCxkDlTl4FvKE5gbXHZSyDmCrPHy2bl7LcHGwE4rs5Dl0DTyXP05j%2FjlM4u3a0vuyXtOuyy0%2BLsyefzFJsP%2BlOXKhfSXrhzbBvyoHQe5nDRLt%2FDYmlnwV%2FjyMNbhR5G1X9sBlJ7ak3DRtAa%2BkOTI19NcUw8MwwJxrC%2FcsVvlsJ6seBF4tuxtitexjkNXc1Lh%2F9WwPcKIuLvpQGMjkVHbZWcqmX9uWakW%2F%2BF97TVMymEBMgP6FdDRX5sbAuoq6cRqxBNrwg1XNET%2FFZRmDTAAmRCIpge%2FU%3D&X-Amz-SignedHeaders=host&X-Amz-Signature=4bfcccc9c97b741fd70fd6757e9054396cd75d77b3d986c500332082752aa4cd https://vaww.infoshare.va.gov/sites/chio/NCRW/NCR/Install%20Guides/Forms/AllItems.aspx?RootFolder=%2Fsites%2Fchio%2FNCRW%2FNCR%2FInstall%20Guides%2FUpdate_2_0_223%20VA-REMOTE%20TEMPERATURE%20MONITORING

REFERENCES:

1. Lavery, L. A., Higgins, K. R., Lanctot, D. R., Constantinides, G. P., Zamorano, R.

G., Armstrong, D. G., Athanasiou, K. A., and Agrawal, C. M. (2004) Home monitoring of foot skin temperatures to prevent ulceration. Diabetes Care, 27, 2642-2647.

2. Lavery, L. A., Higgins, K. R., Lanctot, D. R., Constantinides, G. P., Zamorano, R.

G., Athanasiou, K. A., Armstrong, D. G., and Agrawal, C. M. (2007) Preventing diabetic foot ulcer recurrence in high-risk patients use of temperature monitoring as a self-assessment tool. Diabetes Care, 30, 14-20.

3. Armstrong, D. G., Holtz-Neiderer, K., Wendel, C., Mohler, M. J., Kimbriel, H. R., and Lavery, L. A. (2007) Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. The American Journal of Medicine, 120, 1042-1046.

4. Frykberg RG, Zgonis T, Armstrong DG, et al.;American College of Foot and

Ankle Surgeons. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg 2006; 45(Suppl.):S1-S66.

5. Bus SA, van Netten JJ, Lavery LA,et al.; International Working Group on the

Diabetic Foot. IWGDF guidance on the prevention of foot ulcers in at-risk patients with diabetes. Diabetes Metab Res Rev 2016;32(Suppl. 1):16-24.

6. Lavery LA, Davis KE, Berriman SJ, et al. WHS guidelines update: Diabetic foot ulcer treatment guidelines.Wound Repair Regen 2016;24: 112-126.

7. Frykberg RG, Gordon IL, Reyzelman AM, Cazzell SM, Fitzgerald RH, Rothenberg GM, Bloom, JD, Linders DR, Nouvong A, Najafi B. Feasibility and

Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar

Ulcers. Diabetes Care. 2017; 40(7):973-980.

8. Peters EJ, Lavery LA. International Working Group on the Diabetic Foot.

Effectiveness of the diabetic foot risk classification system of the International

Working Group on the Diabetic Foot. Diabetes Care. 2001;24(8):1442-1447.