Clinical trial NCT02624674: Multi-spectral Imaging to Assess Wounds in Peripheral Vascular Disease Patients
Official title: Multi-spectral Imaging to Assess Wounds in Peripheral Vascular Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Peripheral Vascular Disease Patient
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Peripheral vascular disease (PVD) is a common disease of impaired blood flow resulting in the compromised tissue perfusion of lower limbs. PAD patients can experience pain, diminished exercise capacity, and tissue loss, with some ultimately requiring amputation. The economic burden of PVD is significant. In the United States alone, PVD accounts for over $20 billion in annual healthcare related costs.

The demand for the development of an effective method to characterize the viability of PVD wounds has resulted in the emergence of several innovative techniques. Commonly used diagnostic methods are ankle-brachial index (ABI), pulse volume recordings, duplex ultrasonography, venous plethysmography, Transcutaneous oxygen tension (TcPO2), toe pressures, angiography by X-ray, computed tomography, and magnetic resonance imaging. Currently, angiography remains the diagnostic gold standard. However, many of these techniques lack the ability to triage and adequately determine the viability of the wound. In addition, there remains a need for effective triage technologies to help clinicians decide whether surgical management is needed. Early determination of surgical versus conservative management may help to improve patient functional outcomes, reduce mortality rates, and prevent limb amputation.

Near-infrared point spectroscopy (NIRS) is a non-invasively technology with recent applications in PVD wound assessment. To date, studies have demonstrated the validity of NIRS technology in patients with peripheral arterial disease. NIRS measures flow, concentration, and oxygenation of hemoglobin in arterioles, capillaries, and venules several centimeters deep in tissue. The MSID is an evolution of existing NIRS imaging devices and has become a portable and functional commercial device produced by KENT imaging (Calgary, Canada). Using this new and clinically applicable NIRS technology designed for assessing wound perfusion and oxygenation, this study seeks to adequately identify viable from non-viable wounds and to rapidly determine indication for vascular interventions. This technology is well-suited for use in a wound patient population as the measurements times are short and can quickly be used at the patient bed side. As such, this project intends to apply NIR technology to quickly assess PVD in the investigators' patient population.

Detailed description: Peripheral vascular disease (PVD) is a common disease of the elderly, resulting in the compromise of blood flow to the lower limbs. As a consequence of impaired tissue perfusion, PAD patients can experience pain, diminished exercise capacity, and tissue loss, with some ultimately requiring amputation. Globally, lower extremity peripheral artery disease is the third leading cause of atherosclerotic cardiovascular morbidity, affecting over 200 million individuals worldwide. Peripheral vascular disease is becoming more prevalent with the increase of incidence with age and a globally aging population. In 2010, it was estimated that the number of people living with peripheral artery disease increased by 23.5% in the last decade. The economic burden of PVD is significant. In the United States alone, PVD accounts for over $20 billion in annual healthcare related costs. Specifically, non-healing wounds represent a significant portion of this expenditure at more than $3 billion per year.

The demand for the development of an effective method to characterize the viability of PVD wounds has resulted in the emergence of several innovative techniques. Commonly used diagnostic methods are ankle-brachial index (ABI), pulse volume recordings, duplex ultrasonography, venous plethysmography, angiography by X-ray, computed tomography, and magnetic resonance imaging. However, many of these techniques lack the ability to triage and adequately determine the viability of the wound. Ankle brachial index (ABI) is one of the most common screening techniques used to establish the presence of PVD, but it lacks sensitivity in creating sensitive and specific categorization of wounds as viable or non-viable. ABI gives an indication of a hemodynamically significant obstruction, but does not measure blood flow directly. Doppler ultrasound is another common method that can measure arterial blood flow, however some groups suggest that the femoral artery blood flow may not be an accurate hemodynamic indication of muscle ischemia. Magnetic resonance spectroscopy is also a new technique that has been validated in its application to assess PVD. Novel magnetic imaging sequences such as PIVOT (Perfusion, Intravascular Venous Oxygen Saturation) combine Blood Oxygen Level Dependent (BOLD) MRI and Arterial Spin Labeling (ASL) to comprehensively assess the tissue. Despite the strengths that many MRI techniques promise, clinical use limitations remain due to the high costs and availability of resources.

Peripheral vascular disease-induced lower extremity wounds have inadequate perfusion. Currently, there are three major approaches to improve vascular perfusion to the area: medical management, open surgery, and endovascular surgery. Medical management consists of lifestyle modification and management of associated risk factors such as smoking, diabetes mellitus, hyperlipidemia, hypertension, and hypercoagulability. While advances have been made in the medical management of lower extremity ischemia-induced wounds, large arterial revascularization remains the current standard of care. Open bypass surgery is often employed to bypass stenotic arteries and improve perfusion to lower extremity wounds. Over the last two decades, endovascular intervention has emerged as an additional therapy as it is minimally invasive and may have lower associated morbidity and mortality. In addition to improved perfusion of lower extremity wounds by medical management of surgical intervention, local wound care is required to expedite the healing process and prevent infection.

However, there remains a need for effective triage technologies to help clinicians decide whether surgical management is needed. This would allow for early determination of surgical versus conservative management and inpatient versus outpatient management. If surgery is required, patient functional outcomes are improved if it takes place earlier. As well, inpatient management of surgical patients is extremely costly. Outpatient management of patients with peripheral vascular wounds that do not require surgery would significantly reduce the costs associated with surgical intervention.

Near-infrared point spectroscopy (NIRS) non-invasively measures flow, concentration, and oxygenation of hemoglobin in arterioles, capillaries, and venules several centimeters deep in tissue. NIRS is safe and comfortable for patients and is well-suited to measure markers of viability in peripheral vascular disease wounds, including tissue perfusion, oxygenation and hemoglobin. To date, studies have demonstrated the validity of NIRS technology in patients with peripheral arterial disease. The Multi spectrum infrared device (MSID) represents an important evolution of existing NIRS imaging devices, which were designed for the clinical environment. The MSID has become a commercial device produced by KENT imaging (Calgary, Canada) after several animal and clinical trials have validated its use. The MSID is a new generation of NIR imaging devices with enhanced portability and functionality. The MSID is able to monitor many variables, such as cytochrome oxidase as a marker of tissue oxygen utilization, oxygen saturation, perfusion and methemoglobin as a marker of free radical injury. The advantage of the MSID is its capacity to account for skin colour. Melanin absorbs light and attenuates the amount of NIR light received by the camera. The Kent imaging device has unique mathematical algorithms to account for melanin content of the skin. In many previous studies done with NIRS technology in PVD wounds, melanin content was not considered to be a factor as patients demographic was predominantly Caucasian. However, in many multicultural cities where there is a wide variability in patient melanin content, melanin corrections in NIRS imaging are very important.

Using this new and clinically applicable NIRS technology designed for PVD, this study seeks to identify viable from non-viable wounds and to determine the severity of wound in assessing for vascular intervention indication. This technology is well-suited for use in a wound patient population as the measurements times are short and movement of subjects is not an issue. As such, this project intends to apply novel technology that has the capacity to quickly assess wounds as a complication of PVD.

Eligibility criteria: Inclusion Criteria

1. Lower extremity wound from peripheral vascular disease, which has had optimum multi-disciplinary team management for \>4 weeks
2. Wound size of \<10 cm
3. In-patients or out-patients in the care of St.Michael's Hospital (SMH) wound care team
4. Patients aged \>18 years
5. Patients who understand the study, agree to adhere to the treatment and are able to give consent
6. Patients who can be followed by the same investigating team for the whole period of their participation in the study

3.3 Exclusion Criteria

1. Presence of invasive infection requiring intravenous antibiotics or debridement.
2. Significant reduced immunity or high dose corticosteroids (\>10mg Prednisolone) or other second line immune-suppressant
3. Need for total contact cast
4. Patients with known or suspected malignancy in the wound or surrounding tissue.
5. Patients who are participating in another clinical study for peripheral vascular diseae wound management
6. Patients with a known history of poor compliance with medical treatment
7. Foot wounds
8. Diabetic patients who cannot have reliable ABI measurements.

Primary outcomes:
measure: Change from baseline in ABI (scale measurement)
timeFrame: 1 month
measure: Change from baseline in Vascular Doppler (imaging analysis)
timeFrame: 1 month
measure: Change from baseline in Toe pressures (physiological parameter measurement)
timeFrame: 1 month
measure: Change from baseline in Angiography (imaging analysis)
timeFrame: 1 month
measure: Change from baseline in Oxygen saturation from the MSID device (scale measurement)
timeFrame: 1 month
measure: Change from baseline in Total hemoglobin from the MSID device (physiological parameter measurement)
timeFrame: 1 month
measure: Change from baseline in Wound Healing (physiological parameter measurement)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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