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

NCT06421961 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 223

Last updated 2024-06-07

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Limb-Threatening Ischemia

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Monica Ms Pettersson, PhD · Sahlgrenska Academy

  • Joakim Mr Nordanstig, PhD · Sahlgrenska University Hospital

  • Sara Ms Haile, PhD · Karolinska Institutet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2025-04-01
Completion
2026-04-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06421961 on ClinicalTrials.gov