Wound Heal
Conditions
Brief summary
Approximately 178 patients with a venous leg ulcer will be included in the investigation evaluating wound healing. All subjects are randomized to one of two treatment arms with an intervention period of 4 weeks followed by a 8 week standard of care period.
Interventions
DEVICEBiatain Ag
Biatain with silver
DEVICECutimed Siltec Sorbact
comparator device
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has signed informed consent * Is above 18 years of age or above and has full legal capacity * Has venous leg ulcer (C6 of the CEAP classification) with a duration longer than 4 weeks but no longer than 5 years * Has acceptance of compression bandages * Has a wound at risk of infection based on WAR (wounds at risk of infection) score with score of ≥3 points OR has at least three of the following clinical signs of bacterial contamination based on the Therapeutic index for local infections (TILI) score: * Erythema to surrounding skin * Heat * Oedema, induration or swelling * Spontaneous pain or pressure pain * Stalled wound healing * Increase and/or change of color or smell of exudate * Has wound area of min 1x1 cm and max 10x10 cm * Has wound with depth of max 2 cm * Has wound with medium to high level of exudate (but should not require more than 1 dressing change/day) * Has ankle-brachial pressure (ABI) ≥0.8 AND, for patients with diabetes mellitus, additional biphasic Doppler signal up to the ankle * Ability (assessed by the investigator) and willingness to adhere to a 1-month intervention period * For patients with diabetes, has HbA1c ≤ 10%/≤ 86 mmol/mol, measured within the last 3 months prior to inclusion * Should be able to follow the study protocol with the prescribed cleansing product (NaCl) and dressing
Exclusion criteria
* Is pregnant or breastfeeding * Has wounds with exposed tendons, bones, fistulas. Or wounds with cavity, undermined or tunnelling * Has infection requiring antibiotics (also for other reasons than wound infection) OR has received antibiotics within the last 1 week before inclusion * Has been receiving the following medical treatment within the last 4 weeks: immunosup-pression, immunomodulating, cytostatic medi-cation or corticoids (topical except for in the wound, inhalation, and stable systemic treat-ment up to 5 mg per day (stable defined as minimum 4 weeks) is allowed * Has a systemic hematological disease * Has renal insufficiency requiring dialysis * Has advanced heart failure NYHA III/IV * Has a psychiatric illness that inhibits compliance with the study protocol * Has severe congenital immunodeficiency such agammaglobulinemia, severe combined immunodeficiency (SCID) * Has allergy towards silver or other dressing ingredients (including compression therapy) * Has wound with \> 50% necrotic tissue * Treatment of wound with an anti-microbial wound dressing within the last 2 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing | After 4 weeks | Relative wound area change measured by calculation of area based on photo of wound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound area reduction | After 4 weeks | Reaching ≥ 40% wound area change |
| Wound healing | After 12 weeks | Wounds healed after 12 weeks (yes/no assessed by investigator) |
| Quality of Life (based on Wound-Quality of Life-17 questionnaire) | After 4 and 12 weeks | Patient Quality of Life |
Countries
Denmark, Germany, United Kingdom, United States
Outcome results
None listed