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Diabetes Foot Care Clinical Pathway - Orpyx Medical Technologies (DFCCP-Orpyx)

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ClinicalTrials.gov Identifier: NCT02994966
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : May 2, 2018
Sponsor:
Collaborators:
Alberta Innovates Health Solutions
Orpyx Medical Technologies Inc.
Information provided by (Responsible Party):
Catherine Chan, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: Surrosense Other: Standard care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Actual Study Start Date : November 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Surrosense
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
Active Comparator: Standard care
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



Primary Outcome Measures :
  1. Foot ulcer recurrence [ Time Frame: 12 months ]
    hazard ratio


Secondary Outcome Measures :
  1. Time to re-ulceration [ Time Frame: 12 months maximum ]
  2. Patient satisfaction [ Time Frame: Last visit to High Risk Foot Team (maximum 12 months) ]
    Survey

  3. Patient compliance [ Time Frame: Last visit to High Risk Foot Team (maximum 12 months) ]
    Survey

  4. Clinical adoption [ Time Frame: 12 months ]
    Interviews with clinicians

  5. Cost effectiveness [ Time Frame: 12 months ]
  6. Complications rates [ Time Frame: 12 months ]
    new ulceration, ulcer extension, infection, surgical intervention, amputation, hospitalization documented

  7. Determinants of ulcer formation [ Time Frame: 12 months ]
    Pressure and adherence parameters compared with area of ulceration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994966


Contacts
Contact: Catherine B Chan, PhD 780-492-9939 cbchan@ualberta.ca
Contact: Naomi Popeski, PhD 403-809-1148 naomi.popeski@ahs.ca

Locations
Canada, Alberta
Brooks Home Care Recruiting
Brooks, Alberta, Canada, T1R 1B7
Contact: Catherine B Chan, PhD    780-492-9939    cbchan@ualberta.ca   
Contact: Naomi Popeski, PhD    403-809-1148    naomi.popeski@ahs.ca   
Peter Lougheed Centre Not yet recruiting
Calgary, Alberta, Canada, T1Y 6J4
Contact: Catherine B Chan, PhD    780-492-9939    cbchan@ualberta.ca   
Contact: Naomi Popeski, PhD    403-809-1148    naomi.popeski@ahs.ca   
Slave Lake Family Care Clinic Not yet recruiting
Slave Lake, Alberta, Canada, T0G 2A2
Contact: Catherine B Chan, PhD    780-492-9939    cbchan@ualberta.ca   
Contact: Naomi Popeski, PhD    403-809-1148    naomi.popeski@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Alberta Innovates Health Solutions
Orpyx Medical Technologies Inc.

Responsible Party: Catherine Chan, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02994966     History of Changes
Other Study ID Numbers: AICE-201500873
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases