Clinical Validation of Technologies for the Quantitative Characterization of Chronic Wounds

NCT07830849 | Active Not Recruiting

• 1 other identifier: WOUND-PR23-SI_1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic wounds are skin lesions that fail to heal within the expected timeframe and are frequently associated with underlying conditions such as diabetes, cardiovascular disease, obesity, and other chronic diseases. Their assessment is currently based primarily on clinical observation and standardized wound assessment tools. However, clinical evaluation may be affected by inter- and intra-clinician variability, potentially limiting the objectivity and reproducibility of wound characterization and monitoring. This multicenter, interventional, non-profit pilot study aims to investigate the feasibility of using non-invasive imaging technologies to support the quantitative and objective characterization of chronic wounds. The study will evaluate the use of multimodal imaging, including ultrasound, high-resolution digital imaging, infrared thermography, and laser Doppler imaging, in patients with chronic wounds. The primary hypothesis is that the use of complementary non-invasive imaging technologies may provide objective and reproducible information on wound characteristics and may show good agreement with standardized clinical wound assessment. The study will also explore whether the combination of information obtained through different imaging modalities may improve the characterization and monitoring of chronic wounds compared with clinical assessment alone. Approximately 40 adult patients with chronic wounds, including pressure ulcers and venous ulcers, will be enrolled at participating clinical centers. Eligible participants will undergo repeated clinical assessments and non-invasive imaging examinations during the study period. Wound exudate may also be collected at predefined time points for exploratory analyses. The primary objective is to assess the agreement and reproducibility between imaging-based wound characterization and standard clinical assessment. The study will also evaluate the performance of the individual imaging modalities and their combined use in characterizing relevant wound features. Exploratory objectives include investigating the potential of the collected data to support the development of quantitative and predictive approaches for wound assessment and monitoring. The study will also explore the relationship between imaging-derived parameters and biological information obtained from wound exudate. The study is intended as a pilot investigation to generate preliminary evidence on the feasibility and potential clinical value of multimodal imaging for the objective assessment of chronic wounds. The results may provide a basis for future clinical validation studies and for the development of innovative approaches to support chronic wound management.

Conditions

Chronic Wounds

Outcome Measures

Primary Outcomes (3)

• Inter-Rater Agreement of Total BWAT Score Among Clinicians

  Agreement among clinicians in the assessment of chronic wound characteristics will be evaluated using the Bates-Jensen Wound Assessment Tool (BWAT). The total BWAT score, ranging from 13 to 65, will be treated as a continuous variable. Agreement among clinical evaluators will be assessed using the Intraclass Correlation Coefficient (ICC), with 95% confidence intervals, at each predefined assessment time point.

  Days 1, 7, 14, and 21

• Agreement Between Individual Imaging Technologies and Clinical Assessment of BWAT Items

  Each of the four imaging technologies-ultrasound, high-resolution digital imaging, infrared thermography, and laser Doppler imaging-will be evaluated separately for its ability to characterize individual wound features corresponding to items of the Bates-Jensen Wound Assessment Tool (BWAT). For each imaging technology, the imaging-based assessment of individual BWAT items will be compared with the corresponding clinical assessment. Agreement will be evaluated separately for each BWAT item and at each predefined assessment time point using the Overall Coefficient of Concordance (OCCC). Diagnostic performance will additionally be assessed, as applicable, using sensitivity, specificity, overall accuracy, receiver operating characteristic (ROC) curves and area under the ROC curve (AUC), and confusion matrices.

  Days 1, 7, 14, and 21

• Agreement Between Individual Imaging Technologies and Clinical Total BWAT Score

  Each of the four imaging technologies-ultrasound, high-resolution digital imaging, infrared thermography, and laser Doppler imaging-will be evaluated separately with respect to the total Bates-Jensen Wound Assessment Tool (BWAT) score obtained by clinical assessment. The total BWAT score ranges from 13 to 65 and will be treated as a continuous variable. For each imaging technology, the total BWAT score derived from the imaging-based assessment will be compared with the total BWAT score obtained by standard clinical assessment. Agreement between imaging-based and clinical assessments will be evaluated using the Intraclass Correlation Coefficient (ICC), with 95% confidence intervals, at each predefined assessment time point. Diagnostic performance measures may additionally be calculated, as applicable, to characterize the ability of each imaging technology to reproduce the clinically assessed total BWAT score.

  Days 1, 7, 14, and 21

Study Arms (1)

Multimodal Non-Invasive Imaging Assessment

EXPERIMENTAL

Diagnostic Test: Quantitative Imaging-Based Chronic Wound Assessment

Interventions

Quantitative Imaging-Based Chronic Wound Assessment DIAGNOSTIC_TEST

The intervention consists of a multimodal, non-invasive imaging approach for the quantitative assessment of chronic wounds. Participants will undergo wound imaging using complementary imaging modalities, including ultrasound, high-resolution digital imaging, infrared thermography, and laser Doppler imaging. The acquired data will be analyzed to obtain quantitative information on relevant wound characteristics and to support standardized wound assessment. Imaging-based findings will be compared with conventional clinical wound assessment to evaluate their concordance, reproducibility, and potential diagnostic value. Repeated assessments will be performed during the study to explore the potential of the approach for monitoring wound evolution over time.

Multimodal Non-Invasive Imaging Assessment

Eligibility Criteria

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

You may qualify if:

• Patients of both sexes aged over 18 years;
• Patients with a chronic venous or pressure wound. In the case of venous wounds, the diagnosis must be confirmed by Doppler examination. The wound must have been present for at least 6 weeks and show less than 50% reduction in wound area after 30 days of standard treatment;
• Patients with chronic wounds up to Grade III.

You may not qualify if:

• Pregnancy or breastfeeding;
• Patients with signs of systemic infection (MEWS \> 0);
• Patients with active neoplastic disease, hematological disorders affecting coagulation, or systemic inflammatory autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus);
• Individuals unable to manage their own interests or provide valid informed consent, even if represented by a legal representative who has provided consent to participation;
• Ankle-Brachial Index (ABI) \< 0.8;
• Body Mass Index (BMI) \> 40.

Sponsors & Collaborators

• Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna: lead
• Auxilium Vitae Volterra: collaborator
• Centro di Riabilitazione Motoria INAIL: collaborator
• Azienda Ospedaliero, Universitaria Pisana: collaborator

Study Sites (1)

Scuola Superiore Sant'Anna, The BioRobotics Institute

Pontedera, Pisa, 56025, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 21, 2026
• Study Start: April 15, 2026
• Primary Completion: September 24, 2026
• Study Completion: September 24, 2026
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

IT (1)