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

Coloplast A/S13 sites in 4 countries180 target enrollmentJune 29, 2023

ConditionsWound Heal

Overview

Phase: N/A
Intervention: Not specified
Conditions: Wound Heal
Sponsor: Coloplast A/S
Enrollment: 180
Locations: 13
Primary Endpoint: Wound healing
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 29, 2023

End Date

January 29, 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Coloplast A/S

Responsible Party

Sponsor

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
•Oedema, induration or swelling
•Spontaneous pain or pressure pain
•Stalled wound healing
•Increase and/or change of color or smell of exudate

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)

Outcomes

Primary Outcomes

Wound healing

Time Frame: After 4 weeks

Relative wound area change measured by calculation of area based on photo of wound

Secondary Outcomes

Wound area reduction(After 4 weeks)
Quality of Life (based on Wound-Quality of Life-17 questionnaire)(After 4 and 12 weeks)
Wound healing(After 12 weeks)