Pressure-Sensing Insoles in the Neuropathic Ulcer Treatment Pathway

Summary

Diabetic foot ulceration (DFU) is a common complication with a 25% lifetime risk in patients with diabetes. While most of these ulcers can be treated successfully on an outpatient basis, some will persist and become infected. Nearly one fifth of patients with lower-extremity diabetic ulcers will require amputation of the affected limb, resulting in staggering costs for both the patient and the healthcare system. Therapies that promote rapid and complete healing and reduce the need for expensive surgical procedures impact these costs substantially.

The standard of care for the treatment of diabetic foot ulcers is the removable cast walker (RCW). RCW use has demonstrated plantar pressure reduction yet is typically perceived as having compliance issues due to its removable nature. In addressing this limitation, a modified version of the RCW has been developed by wrapping it in a layer of cohesive or plaster bandage. This technique has been termed the "instant" total contact cast (iTCC) derived from the seldom-used, gold standard treatment, the total contact cast (TCC). While ease of application and potential clinical equivalence are clear benefits, the iTCC carries disadvantages on account of its irremovability. For example, frequent dressing changes impractical, yet may be necessary for complex wound care. The goal of this research is to continue inquiry and innovation in this most basic aspect of care, whilst addressing the limitations of past research and failures in this domain.

The investigators propose examining the capability of the SurroSense Rx® smart insole and smartwatch system (Orpyx Medical Technologies Inc., Calgary AB) in managing and monitoring adherence to plantar pressure offloading through alert-based feedback. The insoles are embedded with pressure sensors, which wirelessly communicate with a smartwatch that provides feedback on modifying activity or pressure profile over time. This smartwatch transmits audio, visual, and tactile notifications when excessive pressure-time thresholds under plantar regions of interest have been met. This feedback allows patients to be educated on their plantar pressure, and engages them and their caregivers to manage adherence to offloading. The investigators also propose comparing the healing rates of active neuropathic ulcers using RCWs coupled with the SurroSense Rx® smart insole system to assess whether adjunctive use of the two interventions improves the efficiency of neuropathic ulcer treatment.

Conditions

• Diabetes
• Diabetes Complications
• Neuropathy
• Peripheral Neuropathy
• Diabetic Foot Ulcer

Interventions

DEVICE

SurroSense Rx System

The SurroSense Rx system (Orpyx Medical Technologies Inc., Calgary, AB) is a smart insole system designed to aid in the prevention of plantar pressure ulceration and re-ulceration, and the treatment of active ulcers in neuropathic patients. It comprises two pressure-sensing inserts and a smartwatch display device. The device alerts the user when "safe" pressure and time thresholds have been exceeded so that on-demand offloading can occur.

Sponsors & Collaborators

• University of Calgary

  lead OTHER

Principal Investigators

• Karim Manji, DPM, AACFAS · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2019-05-31

Completion

2019-05-31

Countries

• Canada

Study Locations