Peripheral Arterial Disease Clinical Trial
— WISCROfficial title:
Wound Imaging System to Gather Clinical References: Collection of Clinical References Images for the Second Generation DeepView Wound Imaging System
NCT number | NCT03611361 |
Other study ID # | CP-16-002 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | November 18, 2015 |
Est. completion date | December 2020 |
Verified date | April 2024 |
Source | SpectralMD |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 55 |
Est. completion date | December 2020 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Dr. Dennis Gable | Plano | Texas |
Lead Sponsor | Collaborator |
---|---|
SpectralMD | Baylor Research Institute |
United States,
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
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 |
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