N/A
N=50
Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcers
Venous Leg Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT05873257 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Jun 2025
Primary outcome: Primary: Mean Relative Wound Area Reduction as Indication of Total Wound Healing — 46.3; 43.9 relative wound area reduction (%)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biatain Fiber Ag applied to participants (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Relative Wound Area Reduction as Indication of Total Wound Healing |
46.3; 43.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT05873257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.