## Protocol Section
### Identification Module
**NCT ID:** NCT06421961

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

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

#### Organization Study ID Info
**ID:** AW-trail20240409
#### Organization
**Class:** OTHER
**Full Name:** Sahlgrenska University Hospital, Sweden
### Status Module
#### Completion Date
**Date:** 2026-04-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2025-04-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-15
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sahlgrenska University Hospital, Sweden

#### Responsible Party

**Investigator Affiliation:** Sahlgrenska University Hospital, Sweden

**Investigator Full Name:** Louise Koch-Nielsen

**Investigator Title:** Specialist nurse, PhD student

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Chronic Limb-Threatening Ischemia

**Keywords:**

- Wound Healing

- Artificial Intelligence

- Digital Technology

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 223

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** Assessing the agreement between two methods of measuring the size of arterial wounds.

**Time Frame:** Wounds will be sequentially included until we achieve a sample size of 223 wounds within an estimated timeframe of 52 weeks.

**Description:** 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).

**Measure:** Assessing the agreement between two methods of measuring the depth of arterial wounds.

**Time Frame:** Wounds will be sequentially included until we achieve a sample size of 223 wounds within an estimated timeframe of 52 weeks.

### Eligibility Module

**Eligibility Criteria:** 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),

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gothenburg

**Country:** Sweden

**Facility:** Sahlgrenska University Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Sahlgrenska Academy

**Name:** Monica Ms Pettersson, PhD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Sahlgrenska University Hospital, Sweden

**Name:** Joakim Mr Nordanstig, PhD

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** Karolinska Institutet

**Name:** Sara Ms Haile, PhD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007511

- Term: Ischemia

- ID: D000010335

- Term: Pathologic Processes

- ID: D000012883

- Term: Skin Ulcer

- ID: D000012871

- Term: Skin Diseases

- ID: D000058729

- Term: Peripheral Arterial Disease

- ID: D000050197

- Term: Atherosclerosis

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000016491

- Term: Peripheral Vascular Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17206

- Name: Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M29213

- Name: Peripheral Arterial Disease

- Relevance: LOW

- As Found: Unknown

- ID: M18894

- Name: Peripheral Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2714

- Name: Chronic Limb-Threatening Ischemia

- Relevance: HIGH

- As Found: Chronic Limb-Threatening Ischemia

- ID: M10883

- Name: Leg Ulcer

- Relevance: HIGH

- As Found: Leg Ulcers

- ID: M15686

- Name: Skin Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26188

- Name: Atherosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000089802

- Term: Chronic Limb-Threatening Ischemia

- ID: D000007871

- Term: Leg Ulcer

### Misc Info Module

- Version Holder: 2024-05-31
