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

Sponsor
Coloplast A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05923749
Collaborator
(none)
178
Enrollment
10
Locations
2
Arms
16.1
Anticipated Duration (Months)
17.8
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Biatain Ag
  • Device: Cutimed Siltec Sorbact
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
178 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 29, 2023
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Oct 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Biatain Ag

Device: Biatain Ag
Biatain with silver
Active Comparator: Cutimed Siltec Sorbact

Device: Cutimed Siltec Sorbact
comparator device

Outcome Measures

Primary Outcome Measures

  1. Wound healing [After 4 weeks]

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

Secondary Outcome Measures

  1. Wound area reduction [After 4 weeks]

    Reaching ≥ 40% wound area change

  2. Wound healing [After 12 weeks]

    Wounds healed after 12 weeks (yes/no assessed by investigator)

  3. Quality of Life (based on Wound-Quality of Life-17 questionnaire) [After 4 and 12 weeks]

    Patient Quality of Life

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Has signed informed consent

  • Is above 18 years of age and has full legal capacity

  • Has venous leg ulcer (C6 of the CEAP classification) with a duration longer than 8 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 of exudate

  • Increase and/or change of smell of exudate

  • Has wound area of min 2x2 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 2 weeks before inclusion

  • Has been receiving the following medical treatment within the last 4 weeks: corticoids, immunosuppression, immunomodulating medication or cytostatic

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Detroit foot and ankle Specialists Clinton Township Michigan United States 48038
2 Serena Group Monroeville Pennsylvania United States 15146
3 Katholisches Klinikum Bochum Bochum Germany
4 Krankenhaus Buchholz und Winsen gemeinnüzige GmbH Buchholz Germany
5 Universitätsklinikum Erlangen Erlangen Germany
6 Universitätsklinikum Giessen und Marburg GmbH Gießen Germany
7 WoundConsulting GmbH Uniklinik Halle/Saale Halle Germany
8 Städtisches Klinikum Karlsruhe GmbH Karlsruhe Germany
9 Krankenhaus Reinbek, St Adolf-Stift GmbH Reinbek Germany
10 Universitätsmedizin Rostock Rostock Germany

Sponsors and Collaborators

  • Coloplast A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT05923749
Other Study ID Numbers:
  • CP354
First Posted:
Jun 28, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Varicose Ulcer
Leg Ulcer

Study Results

No Results Posted as of Jul 5, 2023