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

Sahlgrenska University Hospital

Status: Invitation-only

Conditions: Chronic Limb-Threatening Ischemia

Study type: Observational

Funder types: Other

Identifiers

NCT06421961

AW-trail20240409

Details and patient eligibility

About

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.

Enrollment: 223 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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),