Wound Imaging Study to Gather Clinical References for a Device to Assist Selecting Level-of-amputation in PAD Patients

Study Overview
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Brief Summary
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This is a proof-of-concept study to collect images to train a CADe algorithm to predict the correct level of amputation in individuals scheduled for amputation secondary to PAD.

Detailed Description
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SpectralMD has developed an imaging device (DeepView), which simultaneously performs multispectral imaging (MSI) measurements across the visible and infrared spectrum to obtain a quantitative tissue viability assessment. These optical measurements are integrated using a CADe algorithm to categorize microvascular blood flow and provide a quantitative assessment to aid in selecting the appropriate amputation site. The investigators intend to gather data to train the CADe algorithm to predict ultimate healing status of tissue in the lower extremities of individuals suffering from peripheral arterial disease (PAD). The investigators will demonstrate the feasibility of using such an algorithm to accurately predict the location and extent of small vessel disease prior to amputation. Eventually, the invesitgators expect the DeepView to reduce the rate of re-amputation in patients with peripheral arterial disease if used for routine assessment of patients prior to amputation. The aims of the study are as follows: Evaluate performance of a Computer Assisted Detection (CADe) algorithm trained to assist selecting the level-of-amputation in patients with PAD. Identify multispectral signatures that are strongly predictive of viable skin tissue at proposed amputation sites. Create a representative database for training the CADe algorithm.

Official Title
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Wound Imaging System to Gather Clinical References: Collection of Clinical References Images for the Second Generation DeepView Wound Imaging System

Conditions
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Amputation Wound, Peripheral Arterial Disease

Intervention / Treatment
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* Device: SpectralMD DeepView Wound Imaging System 2.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must require amputation on a limb secondary to PAD, defined as arterial insufficiency due to atherosclerosis based on one or more of the following assessments: Ankle brachial index; Duplex ultrasonography showing clinically significant occlusion; Arteriography; or Assessment demonstrating stenosis by arterial calcification. Able to give informed consent, Be at least 18 years of age. Exclusion Criteria: No history of major amputation on the affected limb, or Life expectancy less than 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SpectralMD DeepView Wound Imaging System 2.0|The DeepView is an imaging device which simultaneously performs multispectral imaging (MSI) measurements across the visible and infrared spectrum to obtain a quantitative tissue viability assessment. These optical measurements are integrated using a machine learning (ML) algorithm to categorize microvascular blood flow and provide a quantitative assessment for selection of tissue healing.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized amputation healing assessment | Healing as indicated by: re-epithelialization of tissue within the incision site and no signs of drainage/exudate. | 30-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized amputation healing assessment | Healing as indicated by: re-epithelialization of tissue within the incision site and no signs of drainage/exudate. | 90-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral arterial disease, re-amputation, optical imaging, Computer Assisted Detection (CADe)