Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcers

NCT05873257 | Completed Results

• 1 other identifier: CP358
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to test a new gelling fiber wound dressing with silver on patients with a venous leg ulcer Participants will be asked to wear the test dressing in a four weeks period (+/- 2 days) consisting of 6 study visits, and will have the dressing changed once pr. week at the research facility. The wound will be cleaned, assessed and photos will be uploaded to a digital software system.

Conditions

Venous Leg Ulcer

Keywords

wound healing

Outcome Measures

Primary Outcomes (1)

• Mean Relative Wound Area Reduction as Indication of Total Wound Healing

  Wound area will be measured by obtaining photos of the wounds and measure these afterwards. A planimetric software will be used where the wound is photographed with a ruler of known dimensions placed at the skin near the wound edge and the image is transferred to a computer and opened in the planimetric software. The ruler is used for calibration of linear dimensions at the image. Once the wound border is manually traced with a computer mouse the area of wound is calculated and displayed.

  4 weeks

Study Arms (1)

main arm

OTHER

Non comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a four weeks period with planned dressing changes once pr. week.

Device: Biatain Fiber Ag applied to participants

Interventions

Biatain Fiber Ag applied to participants DEVICE

Intervention involving a wound gelling fiber dressing with silver

main arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has signed informed consent
• Is 18 years or above
• Is capable of following study procedure (assessed by the investigator).
• Has a venous leg ulcer that has failed to progress along the expected wound healing trajectory within 4 weeks
• The shape of the wound should be possible to fit under a 10x10 cm dressing
• The shape and location of the wound should be suitable for photo capture (assessed by the investigator).
• Has at least three of five pre-defined clinical signs of infection; pain between two dressing changes, peri-ulcer skin erythema/inflammation, oedema, malodour, or heavy exudate (assessed by the investigator).
• Has a wound that has medium to high level of exudate (assessed by the investigator).
• Has an ankle to brachial pressure index (ABPI) of 0.8 -1.3
• Agrees to wear compression therapy daily in combination with the test dressing
• Is suitable to use the test product for wound treatment (assessed by the investigator).

You may not qualify if:

• Is pregnant/breastfeeding
• Wound is older than 12 months
• Wound with exposed tendons or bones or has fistulas
• Wound which is undermined or tunneling
• Is currently receiving or has within the past 60 days received radio- and/or chemotherapy (low doses radio- and/or chemotherapy is allowed for other indications than cancer if assessed by investigator not to influence study wound area)
• Known history of skin sensitivity to any components of the treatment dressings
• Intake of antibiotics within one week before the start of the enrolment
• Participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Northumbria Healthcare NHS foundation trust

Ashington, Northumbria, NE630HP, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Strategy Project Manager: Johanne Louise Gotfredsen
• Organization: Coloplast A/S

dkjoat@coloplast.com

004549113350

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: non-comparative, one-armed, open-labelled, multi-centre study

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 24, 2023
• Study Start: July 31, 2023
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: June 3, 2025
• Results First Posted: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)