Trial Outcomes & Findings for Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcers (NCT NCT05873257)

Last Updated: 2025-06-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-06-03

Participant Flow

Participant milestones

Participant milestones
Measure	Main Arm Non comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a four weeks period with planned dressing changes at least once per week. Biatain Fiber Ag applied to participants: Intervention involving a wound gelling fiber dressing with silver
Overall Study STARTED	50
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Main Arm n=50 Participants Non comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a four weeks period with planned dressing changes at least once per week. Biatain Fiber Ag applied to participants: Intervention involving a wound gelling fiber dressing with silver
Age, Categorical <=18 years	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=50 Participants
Age, Categorical >=65 years	40 Participants n=50 Participants
Age, Continuous	75.4 years n=50 Participants
Sex: Female, Male Female	24 Participants n=50 Participants
Sex: Female, Male Male	26 Participants n=50 Participants
Region of Enrollment United Kingdom	50 participants n=50 Participants
Wound area	12.3 cm2 n=50 Participants
Wound age	22.4 weeks n=50 Participants
Signs of infection in the wound	50 participants n=50 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: The primary analysis was based on subjects exposed to investigational device and with reliable baseline assessment of wound area. One subject was omitted (entire wound not captured on photo at baseline). The last observation 'on-treatment' was used in the analysis. The sensitivity analysis was conservatively based on the entire ITT population also including a subject with an unreliable wound area assessment at baseline. The analysis was performed as the primary analysis.

Outcome measures

Outcome measures
Measure	Main Arm n=50 Participants Non comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a four weeks period with planned dressing changes at least once per week. Biatain Fiber Ag applied to participants: Intervention involving a wound gelling fiber dressing with silver
Mean Relative Wound Area Reduction as Indication of Total Wound Healing Primary analysis	46.3 relative wound area reduction (%) Interval 36.5 to 56.2
Mean Relative Wound Area Reduction as Indication of Total Wound Healing Sensitivity analysis	43.9 relative wound area reduction (%) Interval 33.1 to 54.7

Adverse Events

Main Arm

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Main Arm n=50 participants at risk Non comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a four weeks period with planned dressing changes once per week. Biatain Fiber Ag applied to participants: Intervention involving a wound gelling fiber dressing with silver
Cardiac disorders Hospitalised with pulmonary oedema	2.0% 1/50 • Number of events 1 • 4 weeks (+/- 2 days)

Other adverse events

Other adverse events
Measure	Main Arm n=50 participants at risk Non comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a four weeks period with planned dressing changes once per week. Biatain Fiber Ag applied to participants: Intervention involving a wound gelling fiber dressing with silver
Infections and infestations Antibiotics prescribed for study wound	10.0% 5/50 • Number of events 5 • 4 weeks (+/- 2 days)
Infections and infestations Cellulitis (right hand)	2.0% 1/50 • Number of events 1 • 4 weeks (+/- 2 days)
General disorders Increased severe pain at wound site	2.0% 1/50 • Number of events 1 • 4 weeks (+/- 2 days)
General disorders Pain on removing dressing	2.0% 1/50 • Number of events 1 • 4 weeks (+/- 2 days)
General disorders Dressing adhered to the wound/painful	2.0% 1/50 • Number of events 1 • 4 weeks (+/- 2 days)

Additional Information

Clinical Strategy Project Manager: Johanne Louise Gotfredsen

Coloplast A/S

Phone: 004549113350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER