Clinical trial NCT03611361: Wound Imaging Study to Gather Clinical References for a Device to Assist Selecting Level-of-amputation in PAD Patients
Official title: Wound Imaging System to Gather Clinical References: Collection of Clinical References Images for the Second Generation DeepView Wound Imaging System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Amputation Wound
Peripheral Arterial Disease
Keywords: peripheral arterial disease
re-amputation
optical imaging
Computer Assisted Detection (CADe)
Lead sponsor: SpectralMD
Sponsor class: INDUSTRY
Collaborators: name: Baylor Research Institute
First posted: 2018-08-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with peripheral arterial disease in a lower extremity.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Standardized amputation healing assessment
timeFrame: 30-days
Secondary outcomes:
measure: Standardized amputation healing assessment
timeFrame: 90-days
Other outcomes:
Locations:
city: Plano
country: United States
facility: Dr. Dennis Gable
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Dennis Gable, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.