Wound Imaging Study to Gather Clinical References for a Device to Assist Selecting Level-of-amputation in PAD Patients (WISCR)
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|ClinicalTrials.gov Identifier: NCT03611361|
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : October 3, 2019
|Condition or disease||Intervention/treatment|
|Amputation Wound Peripheral Arterial Disease||Device: SpectralMD DeepView Wound Imaging System 2.0|
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|
|Estimated Enrollment :||250 participants|
|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|
- 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.
- 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.
- 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.
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
|Contact: Leah K Gaither||(972) firstname.lastname@example.org|
|United States, Texas|
|Dr. Dennis Gable||Recruiting|
|Plano, Texas, United States, 75093|
|Contact: Lucy Miranda 469-814-4727 email@example.com|
|Principal Investigator:||Dennis Gable, MD||Baylor College of Medicine|