Observational Study to Validate a New Clinical Tool for Assessing Hypergranulation in Wounds Including Venous Leg Ulcers and Surgical Wounds

What this Trial Is About

Researchers are studying hypergranulation HG, a common issue that slows wound healing. The study aims to test a new Hypergranulation Tool designed to help healthcare professionals assess the severity of HG in wounds. This observational study will include 80 to 100 adults and children with HG in venous leg ulcers or complex surgical wounds. The goal is to validate this tools use in clinical practice and inform future treatment studies. Participants will attend 2 to 4 clinic visits where nurses will assess wounds using the Hypergranulation Tool, which grades HG based on five different parameters. Additionally, a device will take 2D wound images to create 3D models for detailed analysis of HG volume and coverage. Patient-reported outcome forms and interviews will also be collected to understand patient experiences. Throughout the study, researchers will compare the Hypergranulation Tool assessments with 3D image analysis and patient feedback to determine how well the tool performs. Safety will be monitored by tracking any adverse events related to the study procedures. The study will last until August 2026, with all assessments aimed at improving HG evaluation in clinical settings.

An Observational Clinical Study to Collect Photographic Data of Wounds With Hypergranulation to Aid Development of a Hypergranulation Clinical Endpoint and Assessment Tool, And Generate Participant Reported Data to Inform Trial Design