Clinical Research Directory

Clinical Validation of Technologies for the Quantitative Characterization of Chronic Wounds

Sponsor: Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

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.

Official title: Pilot Study for the Clinical Validation of Technologies for the Quantitative Characterization of Chronic Wounds

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