Clinical trial NCT05923749: A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg Ulcers
Official title: A Prospective Randomised Controlled Study Demonstrating the Clinical Benefit of Biatain® Ag Relative to Cutimed® Siltec® Sorbact® for the Treatment of Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2023-06-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Wound healing
timeFrame: After 4 weeks
Secondary outcomes:
measure: Wound area reduction
timeFrame: After 4 weeks
measure: Wound healing
timeFrame: After 12 weeks
measure: Quality of Life (based on Wound-Quality of Life-17 questionnaire)
timeFrame: After 4 and 12 weeks
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Royal Research, Corp.
state: Florida
city: North Port
country: United States
facility: Three Rivers Wound and Research Center
state: Florida
city: Clinton Township
country: United States
facility: Detroit foot and ankle Specialists
state: Michigan
city: Omaha
country: United States
facility: SerenaGroup Research Center Omaha
state: Nebraska
city: Monroeville
country: United States
facility: Serena Group
state: Pennsylvania
city: Copenhagen
country: Denmark
facility: Dermato-Venerologisk Afd
city: Aachen
country: Germany
facility: Wundmanagement Gefäßzentrum Aachen Wundmanagement
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum
city: Buchholz
country: Germany
facility: Krankenhaus Buchholz und Winsen gemeinnüzige GmbH
city: Dülmen
country: Germany
facility: ProDerma
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Gießen
country: Germany
facility: Universitätsklinikum Giessen und Marburg GmbH
city: Eastbourne
country: United Kingdom
facility: Pioneer Wound Healing and Lymphedema centres
Study officials:
References: