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

Peripheral Arterial Disease Clinical Trial

— WISCR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03611361
• Other study ID #: CP-16-002
• Status: Terminated
• Start date: November 18, 2015
• Est. completion date: December 2020

Study information

• Verified date: April 2024
• Source: SpectralMD
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: December 2020
• Est. primary completion date: July 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amputation Wound
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Dr. Dennis Gable	Plano	Texas

Sponsors (2)

Lead Sponsor	Collaborator
SpectralMD	Baylor Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (3)

Kono Y, Muder RR. Identifying the incidence of and risk factors for reamputation among patients who underwent foot amputation. Ann Vasc Surg. 2012 Nov;26(8):1120-6. doi: 10.1016/j.avsg.2012.02.011. Epub 2012 Jul 25. — View Citation

Thatcher JE, Li W, Rodriguez-Vaqueiro Y, Squiers JJ, Mo W, Lu Y, Plant KD, Sellke E, King DR, Fan W, Martinez-Lorenzo JA, DiMaio JM. Multispectral and Photoplethysmography Optical Imaging Techniques Identify Important Tissue Characteristics in an Animal Model of Tangential Burn Excision. J Burn Care Res. 2016 Jan-Feb;37(1):38-52. doi: 10.1097/BCR.0000000000000317. — View Citation

Zonios G, Bykowski J, Kollias N. Skin melanin, hemoglobin, and light scattering properties can be quantitatively assessed in vivo using diffuse reflectance spectroscopy. J Invest Dermatol. 2001 Dec;117(6):1452-7. doi: 10.1046/j.0022-202x.2001.01577.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Standardized amputation healing assessment	Healing as indicated by: re-epithelialization of tissue within the incision site and no signs of drainage/exudate.	90-days