A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg Ulcers

Not Applicable

Completed

• Conditions: Wound Heal
• Interventions: Device: Biatain Ag; Device: Cutimed Siltec Sorbact

• Registration Number: NCT05923749
• Lead Sponsor: Coloplast A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-06-28
• Study Start: 2023-06-29
• Primary Completion: 2025-01-29
• Study Completion: 2025-01-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biatain Ag	Biatain Ag	-
Cutimed Siltec Sorbact	Cutimed Siltec Sorbact	-

Primary Outcome Measures

Name	Time	Method
Wound healing	After 4 weeks	Relative wound area change measured by calculation of area based on photo of wound

Secondary Outcome Measures

Name	Time	Method
Wound area reduction	After 4 weeks	Reaching ≥ 40% wound area change
Quality of Life (based on Wound-Quality of Life-17 questionnaire)	After 4 and 12 weeks	Patient Quality of Life
Wound healing	After 12 weeks	Wounds healed after 12 weeks (yes/no assessed by investigator)

Trial Locations

Locations (12)

Royal Research, Corp.; 🇺🇸 Hollywood, Florida, United States

Three Rivers Wound and Research Center; 🇺🇸 North Port, Florida, United States

Detroit foot and ankle Specialists; 🇺🇸 Clinton Township, Michigan, United States

SerenaGroup Research Center Omaha; 🇺🇸 Omaha, Nebraska, United States

Serena Group; 🇺🇸 Monroeville, Pennsylvania, United States

Dermato-Venerologisk Afd; 🇩🇰 Copenhagen, Denmark

Katholisches Klinikum Bochum; 🇩🇪 Bochum, Germany

Krankenhaus Buchholz und Winsen gemeinnüzige GmbH; 🇩🇪 Buchholz, Germany

ProDerma; 🇩🇪 Dülmen, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Universitätsklinikum Giessen und Marburg GmbH; 🇩🇪 Gießen, Germany

Pioneer Wound Healing and Lymphedema centres; 🇬🇧 Eastbourne, United Kingdom