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

Stopped early

Conditions studied: Amputation Wound, Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT03611361

Run by

SpectralMD

People needed

55

Starts

2015-11-18

Expected to finish

2020-12-01

Last updated by the study team

2024-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Dr. Dennis Gable — Plano, Texas, United States

Full record on ClinicalTrials.gov

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