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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06421961
Other study ID # AW-trail20240409
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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),

Study Design


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.
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