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

NCT03611361 | Terminated FDA Device

• 1 other identifier: CP-16-002
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation Wound; Peripheral Arterial Disease

Keywords

peripheral arterial disease; re-amputation; optical imaging; Computer Assisted Detection (CADe)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Standardized amputation healing assessment

  90-days

Interventions

SpectralMD DeepView Wound Imaging System 2.0 DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• No history of major amputation on the affected limb, or
• Life expectancy less than 6 months.

Sponsors & Collaborators

• SpectralMD: lead
• Baylor Research Institute: collaborator

Study Sites (1)

Dr. Dennis Gable

Plano, Texas, 75093, United States

Location

Related 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.

  PMID: 22840342 BACKGROUND

• 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.

  PMID: 11886508 BACKGROUND

• 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.

  PMID: 26594863 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skin punch biopsies

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Dennis Gable, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 2, 2018
• Study Start: November 18, 2015
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)