Diabetes Foot Care Clinical Pathway - Orpyx Medical Technologies

NCT02994966 | Completed

• 1 other identifier: AICE-201500873
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care as one of three significant targets for pan-provincial action. The Diabetes Foot Care Clinical Pathway Project (DFCCPP) aims to optimize methods of early detection and treatment of foot ulcers in an effort to reduce lower limb amputation (LLA) by 50%. The DFCCPP key deliverables apply consistency in assessment, care, treatment and process standards, early intervention and complex wound care management, while optimizing health outcomes. To achieve these deliverables, High Risk Foot Teams (HRFTs) will be implemented across the province starting with three pilot sites (Slave Lake, Brooks, and outpatient clinics at the Peter Lougheed Hospital). The pilot site facilities were selected on the basis of their employing staff with expertise and knowledge in diabetic foot care. The HRFT will assess and treat patients with moderate and high-risk findings, and this care pathway will then be rolled out to all clinicians who perform diabetic foot assessments (Primary Care, Home Care, Diabetes Centers, First Nations Reserves, etc.). In conjunction with the DFCCPP, we will evaluate the efficacy of a technological device developed by Alberta-based small-medium enterprise (SME) to improve diabetic foot outcomes by preventing future wounds in high-risk patients who have recently been treated for active foot ulcers. This technology is the SurroSense Rx® smart insole system (Orpyx Medical Technologies Inc., Calgary AB), a device that provides dynamic offloading guidance to patients, in addition to enabling ongoing adherence tracking by the HRFT. It is hypothesized that early wound detection and treatment will ultimately lead to improvements in wound prevalence, chronic wound care, and reduce the need for surgical intervention, including LLA.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Foot ulcer recurrence

  hazard ratio

  12 months

Secondary Outcomes (7)

• Time to re-ulceration

  12 months maximum

• Patient satisfaction

  Last visit to High Risk Foot Team (maximum 12 months)

• Patient compliance

  Last visit to High Risk Foot Team (maximum 12 months)

• Clinical adoption

  12 months

• Cost effectiveness

  12 months

Study Arms (2)

Surrosense

EXPERIMENTAL

Subjects randomized to this group will receive standard care, including appropriate off-loading and footwear as well as wear SurroSense Rx® in-shoe pressure-sensing arrays, which provide visual and auditory/vibratory feedback alerts (relating to high plantar pressures) and offloading guidance to a watch display intended to assist in the recurrence of diabetic foot ulcers. They will also be advised to perform daily self-checks of their feet for redness, callous and wounds. A daily checklist will be provided to participants to evaluate compliance.

Device: Surrosense

Standard care

ACTIVE COMPARATOR

Subjects randomized to this group will receive standard care, including appropriate off-loading and footwear. They will also be advised to perform daily self-checks of their feet for redness, callous and wounds. A daily checklist will be provided to participants to evaluate compliance.

Other: Standard care

Interventions

Surrosense DEVICE

Surrosense

Standard care OTHER

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of diabetic foot ulcer that has resolved within the past twelve (12) months
• Sensory abnormality with no skin breakdown/ulcer
• Diabetes (according to AAFP diagnostic criteria (8))
• Absent sensation to 10 g monofilament exam at 1 or more sites
• Age \>18y
• One or more pedal pulses palpable or doppler-able on each foot (dorsalis pedis \& posttibialis)
• Ability to understand the use of the technology
• Life expectancy greater than the duration of the study
• Subject is willing and able to maintain the required offloading (as applicable for the location of the ulcer)
• Subject or responsible caregiver is willing to adhere to the routine calibration schedule required for the proper ongoing functioning of the device (i.e., going through a monthly two minute procedure)
• Has footwear that is compatible with the Orpyx device: diabetic shoes, running shoes, walking shoes; either lace-up or Velcro; must have a removable insert or orthotic

You may not qualify if:

• Weight \> 325 lb (147 kg)
• Uncorrected visual impairment
• Active plantar ulceration or skin breakdown
• Presence of severe schema (absence of palpable or dopplerable foot pulses)
• Active Infection
• Abnormal toe, ankle and/or foot range of motion that would preclude the patient's ability to offload pressure alerts
• Gross foot deformity that would impact anatomical plantar pressure distribution (i.e., including Charcot foot deformity, and/or previous partial or complete foot or ray amputation)
• Insoles or orthotics with a hard plastic, or uneven, undersurface
• Patient is being cared for exclusively via Telehealth (i.e. there is no opportunity for hands-on or face-to-face interaction between the patient and the caregiving team)

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Innovates Health Solutions: collaborator
• Orpyx Medical Technologies Inc.: collaborator

Study Sites (3)

Brooks Home Care

Brooks, Alberta, T1R 1B7, Canada

Location

Peter Lougheed Centre

Calgary, Alberta, T1Y 6J4, Canada

Location

Slave Lake Family Care Clinic

Slave Lake, Alberta, T0G 2A2, Canada

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 16, 2016
• Study Start: November 1, 2016
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)