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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

NCT07334717 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-01-14

No results posted yet for this study

Summary

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

  • Wound Complications

Interventions

DIAGNOSTIC_TEST

Hypergranulation Tool Proforma

This is an observational study, no IMP will be used. Patients will continue to receive best evidenced based care. Patients will attend clinic 2-4 times. Investigators will use the Hypergranulation Tool Proforma as designed by a roundtable of clinical experts at each clinic visit to clinically assess wounds for the degree of hypergranulation present. The wound will be clinically reviewed based on 5 parameters. This enables clinicans to quantify the degree of hypergranuation of wounds and allow for assessment of wound healing over clinic visits. This will be compared to 3D images of the wound and already validated Patient Reported Outcome Forms (PROMIS) will be competed and exit patient interviews. The data collected will aim to validate a method for assessment of hypergranulation of wounds in the clinical setting to help inform future Phase II clinical trials.

DEVICE

Device to take 2D images of wounds to allow for construction of a 3D image of the wound to assess degree of hypergranulation

This is an observational study, no IMP will be used. Patients will continue to receive best evidenced based care. Patients will attend clinic 2-4 times. Images using a device creating 2D images to allow for a 3D image to be created of the wound. The 3D image will allow for assessment of the volume/ height of hypergranulation and the percentage of the wound affected. This will also produce data on the use of 3D in assessing wound healing over the clinic visits. investigators will also use the Hypergranulation Tool Proforma as described above and the already validated Patient Reported Outcome Forms (PROMIS) will be competed and exit patient interviews. The data collected will aim to validate a method for assessment of hypergranulation of wounds in the clinical setting to help inform future Phase II clinical trials.

Sponsors & Collaborators

  • Ennogen Healthcare Limited

    lead INDUSTRY

Eligibility

Min Age
2 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07334717 on ClinicalTrials.gov