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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-28

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Wound Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Wounds that will be studied include venous leg ulcers, burns and complex surgical wounds.

Hypergranulation Tool Proforma

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes