Amputation WoundWISCRNCT03611361
Wound Imaging Study to Gather Clinical References for a Device to Assist Selecting Level-of-amputation in PAD Patients
An observational study of Amputation Wound and Peripheral Arterial Disease, run by SpectralMD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation Wound, Peripheral Arterial Disease
- What is being tested?
- SpectralMD DeepView Wound Imaging System 2.0
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients diagnosed with peripheral arterial disease in a lower extremity.
Who may be able to join
- 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.
Who cannot join
- No history of major amputation on the affected limb, or
- Life expectancy less than 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wound Imaging System to Gather Clinical References: Collection of Clinical References Images for the Second Generation DeepView Wound Imaging System
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.
Read the 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.
- Conditions
- Amputation Wound, Peripheral Arterial Disease
- Being tested
- SpectralMD DeepView Wound Imaging System 2.0
- Keywords
- peripheral arterial disease, re-amputation, optical imaging, Computer Assisted Detection (CADe)
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpectralMD DeepView Wound Imaging System 2.0Device
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized amputation healing assessment
Healing as indicated by: re-epithelialization of tissue within the incision site and no signs of drainage/exudate.
Measured: 30-days
Secondary outcomes (1)
Standardized amputation healing assessment
Healing as indicated by: re-epithelialization of tissue within the incision site and no signs of drainage/exudate.
Measured: 90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start18 Nov 2015
- Primary completionJul 2020
- Study completionDec 2020
Why it stopped: Able to reach conclusions about feasibility with number of subjects enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Amputation WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpectralMD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baylor Research Institute
- Responsible party
- Sponsor
- Investigators
- Dennis Gable, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611361
- Sponsor's protocol ID
- CP-16-002
- Acronym
- WISCR
- Status last verified
- Apr 2024
- First submitted
- 26 Jul 2018
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22840342Zonios 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.
PubMed 11886508Thatcher 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.
PubMed 26594863
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Imaging System to Gather Clinical References: Collection of Clinical References Images for the Second Generation DeepView Wound Imaging System
- ClinicalTrials.gov ID
- NCT03611361
- Acronym / sponsor ID
- WISCR / CP-16-002
- Conditions
- Amputation Wound, Peripheral Arterial Disease
- Keywords
- peripheral arterial disease, re-amputation, optical imaging, Computer Assisted Detection (CADe)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Able to reach conclusions about feasibility with number of subjects enrolled.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- SpectralMDIndustry (pharma, biotech, devices)
- Collaborators
- Baylor Research Institute
- Study start
- 18 Nov 2015 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with peripheral arterial disease in a lower extremity.
Key inclusion criteria (7 listed)
- 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:
- Able to give informed consent,
- Be at least 18 years of age.
Key exclusion criteria (2 listed)
- No history of major amputation on the affected limb, or
- Life expectancy less than 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpectralMD DeepView Wound Imaging System 2.0The 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. | Device | – |
Primary outcome
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.
1 secondary outcome
Standardized amputation healing assessment
Time frame: 90-days
Results and safety
The study was stopped early (reason given: Able to reach conclusions about feasibility with number of subjects enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 22840342Kono 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.
- Background: PubMed 11886508Zonios 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.
- Background: PubMed 26594863Thatcher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Gable, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation Wound and Peripheral Arterial Disease, run by SpectralMD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Able to reach conclusions about feasibility with number of subjects enrolled.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized amputation healing assessment (time frame: 30-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03611361, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024; AzTrials last refreshed its copy on 26 Oct 2026.