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

Ennogen Healthcare Limited

Status: Enrolling

Conditions: Wound Complications

Treatments: 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

Study type: Observational

Funder types: Industry

Identifiers

NCT07334717

EHCI HG 04-01

365713 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

100 participants in 1 patient group

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

Treatment:

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

Diagnostic Test: Hypergranulation Tool Proforma