Venous Leg Ulcer
Conditions
Keywords
wound healing
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.
Detailed description
: The clinical investigation is a non-comparative, one-armed, open-labelled, multi-centre study The test product, Biatain Fiber Ag is a non-CE-marked gelling fiber wound dressing, containing silver. The product is intended for moist wound healing and exudate management of moderate to high exuding wounds. The overall purpose of this investigation is to obtain clinical data supporting effectiveness of Biatain Fiber Ag to obtain the CE-mark in EU. The total study duration for the subject will be approximately four weeks, consisting of a four-week test period and 6 study visits (V0/V1, V2, V3, V4 and V5). V5 will also terminate the 4-week study period. The primary endpoint is Mean area wound reduction. The endpoint is used to evaluate clinical performance in terms of relative wound area reduction as an indication of total wound healing.
Interventions
DEVICEBiatain Fiber Ag applied to participants
Intervention involving a wound gelling fiber dressing with silver
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
non-comparative, one-armed, open-labelled, multi-centre study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has signed informed consent 2. Is 18 years or above 3. Is capable of following study procedure (assessed by the investigator). 4. Has a venous leg ulcer that has failed to progress along the expected wound healing trajectory within 4 weeks 5. The shape of the wound should be possible to fit under a 10x10 cm dressing 6. The shape and location of the wound should be suitable for photo capture (assessed by the investigator). 7. 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). 8. Has a wound that has medium to high level of exudate (assessed by the investigator). 9. Has an ankle to brachial pressure index (ABPI) of 0.8 -1.3 10. Agrees to wear compression therapy daily in combination with the test dressing 11. Is suitable to use the test product for wound treatment (assessed by the investigator).
Exclusion criteria
1. Is pregnant/breastfeeding 2. Wound is older than 12 months 3. Wound with exposed tendons or bones or has fistulas 4. Wound which is undermined or tunneling 5. 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) 6. Known history of skin sensitivity to any components of the treatment dressings 7. Intake of antibiotics within one week before the start of the enrolment 8. Participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Relative Wound Area Reduction as Indication of Total Wound Healing | 4 weeks | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Main Arm | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 40 Participants | — |
| Age, Categorical Between 18 and 65 years | 10 Participants | — |
| Age, Continuous | 75.4 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 50 participants | — |
| Sex: Female, Male Female | 24 Participants | — |
| Sex: Female, Male Male | 26 Participants | — |
| Signs of infection in the wound | 50 participants | — |
| Wound age | 22.4 weeks | — |
| Wound area | 12.3 cm2 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 8 / 50 |
| serious Total, serious adverse events | 1 / 50 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Main Arm | Mean Relative Wound Area Reduction as Indication of Total Wound Healing | Primary analysis | 46.3 relative wound area reduction (%) |
| Main Arm | Mean Relative Wound Area Reduction as Indication of Total Wound Healing | Sensitivity analysis | 43.9 relative wound area reduction (%) |