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

A Prospective Randomised Controlled Study Demonstrating the Clinical Benefit of Biatain® Ag Relative to Cutimed® Siltec® Sorbact® for the Treatment of Venous Leg Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Wound Heal
• Intervention / Treatment: Device: Biatain Ag; Device: Cutimed Siltec Sorbact

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Dermato-Venerologisk Afd
• Germany
  • Aachen, Germany, 52066
    • Wundmanagement Gefäßzentrum Aachen Wundmanagement
  • Bochum, Germany, 44791
    • Katholisches Klinikum Bochum
  • Buchholz, Germany, 21244
    • Krankenhaus Buchholz und Winsen gemeinnüzige GmbH
  • Dülmen, Germany, 48249
    • ProDerma
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen
  • Gießen, Germany, 35385
    • Universitätsklinikum Gießen und Marburg GmbH
• United Kingdom
  • Eastbourne, United Kingdom, BN23 8AS
    • Pioneer wound healing and lymphedema centres
• United States
  • Florida
    • Hollywood, Florida, United States, 33021
      • Royal Research, Corp.
    • North Port, Florida, United States, 34289
      • Three Rivers Wound and Research Center
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Detroit foot and ankle Specialists
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • SerenaGroup Research Center Omaha
  • Pennsylvania
    • Monroeville, Pennsylvania, United States, 15146
      • Serena Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biatain Ag	Device: Biatain Ag; Biatain with silver
Active Comparator: Cutimed Siltec Sorbact	Device: Cutimed Siltec Sorbact; comparator device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing	Relative wound area change measured by calculation of area based on photo of wound	After 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Actual): January 29, 2025
• Study Completion (Actual): January 29, 2025

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Varicose Ulcer; Leg Ulcer
• Other Study ID Numbers: CP354

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No