Actively Recruiting
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
Led by Ennogen Healthcare Limited · Updated on 2026-01-14
100
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hypergranulation (HG) is well documented and a known barrier to wound healing. Accurate clinical assessment of wounds is crucial in managing HG and evaluating treatment response. Currently there is no standardised assessment for healthcare professionals to assess the severity of HG. Through a modified Delphi process involving wound care clinical experts, a prototype Hypergranulation Tool has been developed to be used in clinical practice. The Hypergranulation Tool allows assessors to grade HG within wounds as mild, moderate and severe, based on 5 separate parameters. A prospective multi-site observational study based in the United Kingdom of 80-100 adult and paediatric patients with HG within venous leg ulcers (VLU) or complex surgical wounds (CSW) will allow performance testing of the Hypergranulation Tool. Study nurses will assess wounds with the Hypergranulation Tool across 2-4 clinic visits. Data from the use of the tool will be compared with quantitative 3D analysis of the wounds, patient reported outcome and patient interview data, to help determine the validity of the Hypergranulation Tool in the clinical setting. Results from the Observational Study will inform design changes to the Hyergranulation Tool as well as the design of future HG intervention trials.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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).
- A chronic hypergranulation wound which is either a venous leg ulcer unhealed for at least 6 weeks but no longer than 24 weeks, or a surgical wound unhealed for at least 2 weeks but no longer than 24 weeks.
- Presence of a device entering the skin (such as gastrostomy, suprapubic catheter, tracheostomy) exhibiting hypergranulation.
- Hypergranulation raised at least 2 mm above natural skin level or wound base, with area extending at least 10 mm in longest length.
- For venous leg ulcers and surgical wounds, healing must not have progressed by at least 25% in area or length.
- Good general health, medically fit to complete assessments and free from systemic conditions impacting safety.
- Willing and able to attend all scheduled clinical assessments.
- Able to communicate well with the Study Investigator and comply with study expectations.
You will not qualify if you...
- Unable to provide informed consent or assent.
- Unable to complete the scheduled study treatments and assessments.
- Previously recruited into this study.
- Participants younger than 2 years or older than 85 years of age.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
EMS Healthcare
Ellesmere Port, Cheshire, United Kingdom, CH65 4LE
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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