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

Chronic Limb-Threatening Ischemia Clinical Trial

Official title:

Digital Techniques for Measuring Chronic Leg Ulcers in Peripheral Arterial Disease: Aspects of Measurement Precision and Evaluation of Wound Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06421961
• Other study ID #: AW-trail20240409
• Status: Enrolling by invitation
• Start date: August 15, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: June 2024
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 223
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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),

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Leg Ulcer

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the clinical agreement between two methods of measuring arterial wound size, we will utilize the Bland-Altman plot.	The size of the wound will be determined using three different measurement techniques, with images captured during a single session.; Traditional Method for Area Measurement: This method utilizes a Canon EOS 700D camera and a 10 cm ruler for reference. The area is calculated using Picsara software, yielding results in square centimeters (cm²).; SeeWound Method Version 1.6.4 for Area Measurement with reference card: This technique employs a specialized app to calculate the wound area in square centimeters (cm²) with the reference card.; 2. SeeWound Method Version 1.6.4 for Research: This app utilizes lidar technology to measure the area in square centimeters (cm²).	Wounds will be sequentially included until we achieve a sample size of 223 wounds within an estimated timeframe of 52 weeks.
Primary	To assess the clinical agreement between two methods of measuring the depth of arterial wounds, we will utilize the Bland-Altman plot.	The Depth of the wound will be determined using two different measurement techniques, with measurement taken during a single session.; Manual Depth Measurement with a Cotton Swab: A cotton swab is inserted into the wound to measure its depth. The measurement is taken at the deepest point and recorded in millimeters (mm).; SeeWound Method Version 1.6.4 for Research: This app utilizes lidar technology to measure the depth of the wound in millimeters (mm).	Wounds will be sequentially included until we achieve a sample size of 223 wounds within an estimated timeframe of 52 weeks.