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

April 15, 2024 updated by: SpectralMD

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Device: SpectralMD DeepView Wound Imaging System 2.0

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Texas
  - Plano, Texas, United States, 75093
    - Dr. Dennis Gable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed with peripheral arterial disease in a lower extremity.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized amputation healing assessment Time Frame: 30-days	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 Time Frame: 90-days	Healing as indicated by: re-epithelialization of tissue within the incision site and no signs of drainage/exudate.	90-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SpectralMD

Collaborators

Baylor Research Institute

Investigators

Principal Investigator: Dennis Gable, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2015

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria