Agreement Study on AI-assisted Smartphone-based Monitoring Tool for Difficult-to-heal Ischemic Leg Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

223 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-15

Study Completion Date

2026-04-01

Brief Summary

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The purpose of the project is to investigate the agreement with Bland-Altman plots between an AI-supported automatic digital measurement method of wound area and depth and existing manual measurement methods in patients with arterial ulcers on the lower leg. The expectation is that the digital measurement tool can provide healthcare providers with better opportunities to objectively monitor and detect changes in the wound healing process in patients with peripheral arterial disease.

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Detailed Description

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Conditions

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Chronic Limb-Threatening Ischemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults with peripheral arterial disease.
* Arterial or arteriovenous ulcers on lower leg
* Age \<18

Exclusion Criteria

* Adults with non-ischemic ulcers,
* Purely venous ulcers,
* Purely traumatic wounds,
* Wounds resulting from non-atherosclerotic chronic vascular conditions of the lower extremity (e.g.,vasculitis, Buerger disease, radiation arteritis),

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No