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

Wound Heal Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05923749
• Other study ID #: CP354
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: March 2024
• Source: Coloplast A/S
• Contact: Lisa Teen O'Dwyer
• Phone: +4549111279
• Email: dklito[@]coloplast.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Varicose Ulcer
• Wound Heal

Intervention

Device:
• Biatain Ag
Biatain with silver
• Cutimed Siltec Sorbact
comparator device

Locations

Country	Name	City	State
Denmark	Dermato-Venerologisk Afd	Copenhagen
Denmark	Nordsjællands Hospital Hillerød	Hillerød
Denmark	Sygehus Lillebælt Kolding	Kolding
Germany	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	WoundConsulting GmbH Uniklinik Halle/Saale	Halle
Germany	Städtisches Klinikum Karlsruhe GmbH	Karlsruhe
Germany	Krankenhaus Reinbek, St Adolf-Stift GmbH	Reinbek
Germany	Klinik und Poliklinik für Dermatologie and Venerologie	Rostock
United States	Detroit foot and ankle Specialists	Clinton Township	Michigan
United States	Royal Research, Corp.	Hollywood	Florida
United States	Armstrong County Memorial Hospital - Wound Clinic	Kittanning	Pennsylvania
United States	Serena Group	Monroeville	Pennsylvania
United States	Three Rivers Wound and Research Center	North Port	Florida
United States	SerenaGroup Research Center Omaha	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

United States,  Denmark,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing	Relative wound area change measured by calculation of area based on photo of wound	After 4 weeks
Secondary	Wound area reduction	Reaching = 40% wound area change	After 4 weeks
Secondary	Wound healing	Wounds healed after 12 weeks (yes/no assessed by investigator)	After 12 weeks
Secondary	Quality of Life (based on Wound-Quality of Life-17 questionnaire)	Patient Quality of Life	After 4 and 12 weeks