Wound ComplicationsNCT07334717
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
An observational study of Wound Complications, run by Ennogen Healthcare Limited at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Complications
- What is being tested?
- Hypergranulation Tool Proforma and Device to take 2D images of wounds to allow for construction of a 3D image of the wound to assess degree of hypergranulation
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Apr 2026to 29 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Approximately 80-100 participants who meet the inclusion criteria will be be recruited into the study. Participants will be recruited from tissue viability clinics, burns clinics and wound care clinics across the North West of England.
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Hypergranulation Tool Proforma, Device to take 2D images of wounds to allow for construction of a 3D image of the wound to assess degree of hypergranulation
- Keywords
- Hypergranulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypergranulation Tool ProformaDiagnostic 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 hypergranulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Wounds that will be studied include venous leg ulcers, burns and complex surgical wounds. | Not described Receives: Diagnostic Test: Hypergranulation Tool Proforma; Device: Device to take 2D images of wounds to allow for construction of a 3D image of the wound to assess degree of hypergranulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the performance of 3-D photographs as a tool to assess HG wound tissue as compared to Hypergranulation Tool Proforma clinical asssesment
3D images will be compared to the clinical assessment by the Hypergranulation Tool Proforma which assesses wounds based on 5 components (bleeding and friability, colour, height, exudate, and size [percentage of wound affected])
Measured: August 2026
Secondary outcomes (5)
To conduct and evaluate the assessment of wound healing percentage through 3-D photography compared to Study Investigator assessment with the Hypergranulation Tool
Measured: August 2026
To determine the performance of 3-D photographs in assessing HG wound tissue coverage compared to assessments made by a Study Investigator with the Hypergranulation Tool Proforma
Measured: August 2026
To assess the participant reported experience of HG of wound tissue through participant reported outcomes (PROs) and participant interviews
Measured: August 2026
To determine the performance of 3-D photographs in assessing height of HG wound tissue compared to assessments made by a Study Investigator with the Hypergranulation Tool
Measured: August 2026
To assess study-emergent adverse events (AEs) that are linked to study assessments.
Measured: August 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start8 Apr 2026
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Why it stopped: Study terminated due to low recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ennogen Healthcare Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334717
- Sponsor's protocol ID
- EHCI HG 04-01
- Other IDs
- 365713
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07334717
- Acronym / sponsor ID
- EHCI HG 04-01
- Conditions
- Wound Complications
- Keywords
- Hypergranulation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated due to low recruitment.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Ennogen Healthcare LimitedIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wounds that will be studied include venous leg ulcers, burns and complex surgical wounds. | – | Diagnostic Test: Hypergranulation Tool Proforma, Device: Device to take 2D images of wounds to allow for construction of a 3D image of the wound to assess degree of hypergranulation |
Who may qualify
- Ages
- 2 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 80-100 participants who meet the inclusion criteria will be be recruited into the study. Participants will be recruited from tissue viability clinics, burns clinics and wound care clinics across the North West of England.
Key inclusion criteria (14 listed)
- 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 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypergranulation Tool ProformaThis 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. | Diagnostic test | Wounds that will be studied include venous leg ulcers, burns and complex surgical wounds. |
| Device to take 2D images of wounds to allow for construction of a 3D image of the wound to assess degree of hypergranulationThis 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. | Device | Wounds that will be studied include venous leg ulcers, burns and complex surgical wounds. |
Primary outcome
To determine the performance of 3-D photographs as a tool to assess HG wound tissue as compared to Hypergranulation Tool Proforma clinical asssesment
Time frame: August 2026
3D images will be compared to the clinical assessment by the Hypergranulation Tool Proforma which assesses wounds based on 5 components (bleeding and friability, colour, height, exudate, and size [percentage of wound affected])
5 secondary outcomes
To conduct and evaluate the assessment of wound healing percentage through 3-D photography compared to Study Investigator assessment with the Hypergranulation Tool
Time frame: August 2026
To determine the performance of 3-D photographs in assessing HG wound tissue coverage compared to assessments made by a Study Investigator with the Hypergranulation Tool Proforma
Time frame: August 2026
To assess the participant reported experience of HG of wound tissue through participant reported outcomes (PROs) and participant interviews
Time frame: August 2026
To determine the performance of 3-D photographs in assessing height of HG wound tissue compared to assessments made by a Study Investigator with the Hypergranulation Tool
Time frame: August 2026
To assess study-emergent adverse events (AEs) that are linked to study assessments.
Time frame: August 2026
Results and safety
The study was stopped early (reason given: Study terminated due to low recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Complications, run by Ennogen Healthcare Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to low recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the performance of 3-D photographs as a tool to assess HG wound tissue as compared to Hypergranulation Tool Proforma clinical asssesment (time frame: August 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.