Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02994966 |
| Other study ID # |
AICE-201500873 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2016 |
| Est. completion date |
February 26, 2020 |
Study information
| Verified date |
June 2022 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The Canadian Institute of Health Information estimates that foot wounds (with diabetes as the
leading cause) are present in 4% of all hospital inpatients, 7% of homecare clients and 10%
of long-term care (LTC) residents. Of 210,000 people with diabetes in Alberta, 5,250 will
seek treatment of a foot ulcer annually. In Alberta in 2014-15 there were 425 LLAs performed
on 309 diabetic patients representing an increase of 89 LLA over 2010-11. Moreover, there is
a tremendous reduction in quality of life of the patients and attendant negative effects on
their families. The 5-year mortality rate after a new-onset diabetic foot ulcer is 43-55%,
and is as high as 74% for patients undergoing LLA.
Continuous monitoring of the diabetic foot and preventative foot care is of utmost importance
for patients with diabetes. This is especially the case in high risk patients who have
previously had foot ulcers. Improving and standardizing diabetic foot screening, early wound
detection and treatment will ultimately lead to improvements in wound prevalence, chronic
wound care, and the need for surgical intervention, including amputation.
Effective pressure offloading is a key tenet of diabetic ulcer prevention and care. The
effectiveness of offloading interventions is intimately linked to the skin reperfusion that
is seen when persistent external pressure is alleviated. Key modifiable parameters in
mitigating tissue damage to the neuropathic foot are pressure and time. Exposures from 15 min
to one hour at pressures greater than 240 mmHg, and from two hours or more at pressures
greater than 67 mmHg, were found to cause cell death in rat muscle tissue. Despite this,
there is limited information regarding the efficacy of interventions aimed at preventing
pressure ulcers; a comprehensive review of the literature did not find enough evidence to
recommend a repositioning frequency. A consensus document from an international review on
pressure ulcer prevention states "patients confined to wheelchairs should be taught to
reposition every 15 minutes".
While established pressure offloading interventions are able to statically reduce pressure on
the active ulcer, they provide no dynamic relief of pressure. Since neuropathy is
characterized by a loss of protective sensation (LOPS), the patient is often unaware of
sustained pressure on a specific anatomic region over time. Even with static offloading
instruments, it is conceivable that critical pressure and time thresholds can be dynamically
exceeded without the patient's knowledge or ability to address the problem. Taken together,
the literature provides support for a system that monitors pressure over time at key
locations, and provides alert-based feedback to guide as-needed, patient-based offloading for
use in patients with active ulceration.
Orpyx Medical Technologies Inc. (Orpyx), has developed a smart insole technology (the
"SurroSense Rx®") that senses pressure points in the user'splantar foot. This is important
because pressure "hot spots" can lead to wound development that, if left untreated, can
progress to a foot ulcer and LLA. Individuals able to maintain lower in-shoe peak pressures
had 60% lower risk of foot ulcer recurrence. Unpublished studies with this device are
demonstrating an 83% relative risk reduction in plantar ulceration in active versus control
arms. This device provides dynamic offloading guidance to patients, in addition to enabling
ongoing adherence tracking. This device has been shown to be an effective treatment in the
management of diabetic foot patients at risk for ulcers, with respect to the care of active
ulcers, in addition to prevention of future recurrence. Wearers of the SurroSense Rx®
technology are provided with on demand cues for offloading, and should therefore have
enhanced responsiveness and self-control over their foot care, thereby leading to a reduction
in re-ulcerative events and thus, LLA.
The SurroSense Rx® system is a patent pending (US Publication 20120109013 and PCT
WO/2012/055029) footwear system intended to prevent first and recurrent plantar ulcers, and
to treat 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; the current thresholds are based on the results of a
comprehensive review of the literature, which indicates that a conservative threshold would
be >30-50mmHg for >15 minutes. As more plantar pressure and outcome data are collected over
time, these thresholds may be modified as need be. The device measures plantar pressures at
discrete points corresponding to bony prominences that would be considered to be at higher
risk for ulceration: the first metatarsal head (1), the lateral metatarsal heads (2), the
great toe (1), the lateral toes (1), the lateral foot (2), and the heel (1). These areas were
selected based on the inherent high risk of neuropathic ulceration at these anatomic
locations. This data is tracked, with analysis being performed on those that have been
collected over the last 15 minutes. If > 95% of the measurements taken by a pressure sensor
over a 15-minute scanning window exceed 30-50 mmHg, an alert is sent to the user via the
smartwatch to guide them to appropriately offload that area.
The SurroSense Rx® device will be used as an adjunct in the treatment pathway following
closure of diabetic foot wounds. It is widely acknowledged that, following wound healing,
50-100% of diabetic foot ulcers recur over a five-year period. What is more, it is estimated
that after 18 months, 42% of ulcers recur, with half of those recurring in the first six
months. Thus, it is the first six months following wound healing that is the most sensitive
time for recurrence of ulceration. It is this critical patient population that will be fitted
with the SurroSense Rx® device for secondary prevention of ulceration.
Taken together, diabetes patients with foot wounds are at an elevated risk of infection and
LLA. Therefore, there is a need for an effective tool for the prevention and management of
the diabetic foot.
Research Question and Objectives:
Does improving and standardizing foot screening for diabetes patients through the DFCCP
concurrently with the use of the SurroSense Rx® smart insole system reduce the proportion of
foot ulcer recurrence compared to patients who are receiving standard care? The objective of
this proposal is to demonstrate that when combined with the DFCCP, the SurroSense Rx® smart
insole system device is an effective modality that is superior to the current standard of
care for preventing the recurrence of healed pressure ulcerations on the feet of subjects
with diabetic peripheral neuropathy of the lower extremities. It is hypothesized that the use
of the device will lead to a reduction in the risk of pressure ulcer recurrence in the
Intervention group and to improve those subjects' foot self-care, when compared to subjects
in the Control group. Over the longer term we anticipate that use of the technology in
concert with the DFCCP will result in better foot health for diabetic patients. The ability
to test the efficacy of the SurroSense Rx® device in parallel with the DFCCP implementation
will allow the evaluation in a real-world setting where patients also have access to HRFT for
prescription of the device. High Risk Foot Teams will be implemented across the province
starting with three pilot sites (Slave Lake, Brooks, and the Diabetic Foot and Limb
Preservation Centre at the Peter Lougheed Hospital), These pilot sites will be selected as
facilities have existing staff with expertise and knowledge in diabetic foot care. The HRFT
will assess and treat patients with moderate and high-risk findings. The AICE-funded project
is a sub-study. All patients are clinically assessed in a standardized manner using the
Alberta Foot Risk Assessment Form (AFRAF), which incorporates a standardized wound assessment
and treatment approach.ces, ongoing assessment and embedded evaluation.
