Collecting wound photos to create and test a hypergranulation assessment tool
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
This project will test a new Hypergranulation Tool—using nurse ratings and 3D wound images—for children and adults with hypergranulation in venous leg ulcers, unhealed surgical wounds, or device-entry sites.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 2 Years to 85 Years |
| Sex | All |
| Sponsor | Ennogen Healthcare Limited Industry-sponsored |
| Locations | 1 site (Ellesmere Port, Cheshire) |
| Trial ID | NCT07334717 on ClinicalTrials.gov |
What this trial studies
A prospective, multi-site observational project in the United Kingdom will enroll about 80–100 adult and paediatric participants with hypergranulation in venous leg ulcers, complex surgical wounds, or device-entry sites. A prototype Hypergranulation Tool developed via a modified Delphi process will be used by study nurses to grade wounds as mild, moderate, or severe across 2–4 clinic visits. Wound assessments using the tool will be compared against quantitative 3D image analysis constructed from 2D photos, and participant-reported information will be collected to help design future trials. The aim is to test the tool's performance and practical use in routine clinical settings.
Who should consider this trial
Good fit: Ideal candidates are males or females aged 2–85 with a chronic hypergranulation wound (venous leg ulcer unhealed 6–24 weeks, surgical wound unhealed 2–24 weeks, or device-entry site) where the hypergranulation is raised at least 2 mm and extends at least 10 mm, and the wound has not reduced in size by 25% or more.
Not a fit: Patients whose wounds fall outside the duration, size, or hypergranulation depth criteria, those with fully healed or rapidly healing wounds, or those unable to attend in-person clinic visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, clinicians would have a standard, repeatable way to grade hypergranulation so treatment choices and healing progress can be tracked more consistently.
How similar studies have performed: This is largely novel because there is currently no standardized clinical assessment for hypergranulation and comparable prospective validation studies are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Male or female participants between 2 to 85 years of age (both inclusive). * Willing and able to provide written informed consent or assent (as applicable) as evidenced by signature on the participant's consent/assent form. In case if the child is providing assent, a caregiver or LAR must sign an informed consent. * A chronic HG wound which can be: * a VLU unhealed for a minimum of 6 weeks, but no longer than 24 weeks * an unhealed surgical wound that has been unhealed for at least 2 weeks but no longer than 24 weeks * a device entering the skin (eg, gastrostomy, suprapubic catheter, tracheostomy etc) that exhibits HG. * A degree of HG that is estimated to be raised at least 2 mm above the natural skin level, or above the base of the wound and an area of HG extending at least 10 mm in its longest length. * For VLU and surgical wounds, the wound should not have been healed by at least 25% area or length. * Have good general health as defined by: * medically fit enough to complete the study assessments * free of any other systemic condition that in the opinion of the Study Investigator may have an impact on the safety of the participant. * Be willing and able to attend all scheduled clinical assessments, (adults or caregiver) * able to communicate well with the Study Investigator and willing and able to comply with the expectations of the study. * This includes gastrostomy; suprapubic catheters, tracheostomy, other tube/catheter skin entry or exit sites, abdominal surgical wound, pilonidal sinus surgical site, split-skin donor site, plastic surgery sites, healing burn sites, peri-anal surgical wounds, gastrointestinal stoma, other. Exclusion Criteria * Unable to provide informed consent or assent * Unable to complete the scheduled study treatments and assessments * Have been previously recruited into this study * Participants who are \< 2 years or \>85 years of age
Where this trial is running
Ellesmere Port, Cheshire
- EMS Healthcare — Ellesmere Port, Cheshire, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.