Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03611361
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
Baylor Research Institute
Information provided by (Responsible Party):
SpectralMD

Brief Summary:
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.

Condition or disease Intervention/treatment
Amputation Wound Peripheral Arterial Disease 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Wound Imaging System to Gather Clinical References: Collection of Clinical References Images for the Second Generation DeepView Wound Imaging System
Actual Study Start Date : November 18, 2015
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients diagnosed with peripheral arterial disease in a lower extremity.
Criteria

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.

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): NCT03611361


Contacts
Layout table for location contacts
Contact: Leah K Gaither (972) 499-4934 gaither@spectralmd.com

Locations
Layout table for location information
United States, Texas
Dr. Dennis Gable Recruiting
Plano, Texas, United States, 75093
Contact: Lucy Miranda    469-814-4727    lucy.miranda@bswhealth.org   
Sponsors and Collaborators
SpectralMD
Baylor Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Dennis Gable, MD Baylor College of Medicine
Publications:
Layout table for additonal information
Responsible Party: SpectralMD
ClinicalTrials.gov Identifier: NCT03611361    
Other Study ID Numbers: CP-16-002
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by SpectralMD:
peripheral arterial disease
re-amputation
optical imaging
Computer Assisted Detection (CADe)
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Arterial Disease
Peripheral Vascular Diseases
Wounds and Injuries
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases