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

NCT06421961 | Enrolling By Invitation

• 1 other identifier: AW-trail20240409
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Wound Healing; Artificial Intelligence; Digital Technology

Outcome Measures

Primary Outcomes (2)

• 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. 1. 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). 2. 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.

• 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. 1. 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). 2. 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patienten seeking care and being diagnos with peripheral arterial disease and having hard to heal wounds on lower leg or foot.

You may qualify if:

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

You may not qualify if:

• 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),

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Monica Ms Pettersson, PhD

  Sahlgrenska Academy

  STUDY DIRECTOR

• Joakim Mr Nordanstig, PhD

  Sahlgrenska University Hospital

  STUDY CHAIR

• Sara Ms Haile, PhD

  Karolinska Institutet

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist nurse, PhD student

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: May 20, 2024
• Study Start: August 15, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

SE (1)