Observational Study of Hypergranulated Wounds - EHCI HG 04-01
Research type
Research Study
Full title
An Observational Clinical Study to Collect Photographic Data of Wounds with Hypergranulation to Aid Development of a Hypergranulation Clinical Endpoint and an Assessment Tool, and Generate Participant Reported Data to Inform Trial Design
IRAS ID
365713
Contact name
Ben Nurdin
Contact email
Sponsor organisation
Ennogen Healthcare International Ltd.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Not applicable, Not applicable
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
The purpose of this study is to figure out how effective 3-D photographs are for assessing hypergranulation tissue in wounds. Hypergranulation is an overgrowth of tissue that rises above the wound surface and can delay healing.
Wound healing happens in stages: first the bleeding stops, then the area becomes inflamed, then new tissue grows, and finally the wound matures. During healing, healthy tissue called granulation helps close the wound. Sometimes this process goes out of balance, and extra tissue called hypergranulation forms. This extra tissue can slow down skin growth and delay healing.
This study will look at how 3-D photos can help in understanding wounds with hypergranulation. These photos will be compared with the wound assessments done by the clinical research nurse. The goal is to create clear ways to measure this extra tissue, develop a tool for future care, and to learn what works best for patients in future studies.
The study will have a maximum of 4 total visits and 1 virtual or telephone exit interview. Participants will be in the study for up to 16 weeks. Approximately 100 adults and children will join this study in the United Kingdom. The study is sponsored by Ennogen Healthcare International Ltd.REC name
West of Scotland REC 1
REC reference
26/WS/0014
Date of REC Opinion
10 Feb 2026
REC opinion
Further Information Favourable Opinion