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

Primary Purpose

Wound Heal

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Biatain Ag
Cutimed Siltec Sorbact
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Heal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Avail Primary Care Clinic
  • Three Rivers Wound and Research Center
  • Detroit foot and ankle SpecialistsRecruiting
  • Serena Group
  • Dermato-Venerologisk Afd
  • Nordsjællands Hospital Hillerød
  • Sygehus Lillebælt Kolding
  • Katholisches Klinikum Bochum
  • Krankenhaus Buchholz und Winsen gemeinnüzige GmbH
  • Universitätsklinikum ErlangenRecruiting
  • Universitätsklinikum Giessen und Marburg GmbHRecruiting
  • WoundConsulting GmbH Uniklinik Halle/Saale
  • Städtisches Klinikum Karlsruhe GmbH
  • Krankenhaus Reinbek, St Adolf-Stift GmbHRecruiting
  • Klinik und Poliklinik für Dermatologie and Venerologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biatain Ag

Cutimed Siltec Sorbact

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 14, 2023
Last Updated
September 15, 2023
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05923749
Brief Title
A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg Ulcers
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biatain Ag
Arm Type
Experimental
Arm Title
Cutimed Siltec Sorbact
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Biatain Ag
Intervention Description
Biatain with silver
Intervention Type
Device
Intervention Name(s)
Cutimed Siltec Sorbact
Intervention Description
comparator device
Primary Outcome Measure Information:
Title
Wound healing
Description
Relative wound area change measured by calculation of area based on photo of wound
Time Frame
After 4 weeks
Secondary Outcome Measure Information:
Title
Wound area reduction
Description
Reaching ≥ 40% wound area change
Time Frame
After 4 weeks
Title
Wound healing
Description
Wounds healed after 12 weeks (yes/no assessed by investigator)
Time Frame
After 12 weeks
Title
Quality of Life (based on Wound-Quality of Life-17 questionnaire)
Description
Patient Quality of Life
Time Frame
After 4 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Teen O'Dwyer
Phone
+4549111279
Email
dklito@coloplast.com
Facility Information:
Facility Name
Avail Primary Care Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
70605
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Johnson
Email
ljohnson@lc.availhospitals.com
First Name & Middle Initial & Last Name & Degree
Lexie Reed Kober, APRN
Facility Name
Three Rivers Wound and Research Center
City
North Port
State/Province
Florida
ZIP/Postal Code
34289
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Swartz
Email
cyndiloohoo15@gmail.com
First Name & Middle Initial & Last Name & Degree
Keyur Patel, DO
Facility Name
Detroit foot and ankle Specialists
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Loder
Email
bloder@detroitfa.com
Facility Name
Serena Group
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Neil
Email
mneil@serenagroups.com
Facility Name
Dermato-Venerologisk Afd
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stine Ørts Pedersen
First Name & Middle Initial & Last Name & Degree
Klaus Kirketerp-Møller, MD
Facility Name
Nordsjællands Hospital Hillerød
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonas Askø Andersen
Facility Name
Sygehus Lillebælt Kolding
City
Kolding
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Christian Houlind
Facility Name
Katholisches Klinikum Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maren Hoffmann
Email
maren.hoffmann@kklbo.de
First Name & Middle Initial & Last Name & Degree
Markus Stücker, Proff.
Facility Name
Krankenhaus Buchholz und Winsen gemeinnüzige GmbH
City
Buchholz
ZIP/Postal Code
21244
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Heger
Email
Susanne.Heger@klinikum-karlsruhe.de
First Name & Middle Initial & Last Name & Degree
Holger Diener, MD
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigrun Bregenzer
Email
Sigrun.Bregenzer@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Cornelia Erfurt-Berge, PD. MD
Facility Name
Universitätsklinikum Giessen und Marburg GmbH
City
Gießen
ZIP/Postal Code
35385
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Arved Christian Kretzer
Email
John.A.Kretzer@med.uni-giessen.de
First Name & Middle Initial & Last Name & Degree
Melanie Spaenig
Email
melanie.spaenig@chiru.med.uni-giessen.de
First Name & Middle Initial & Last Name & Degree
Johannes Kalder, Prof. MD
Facility Name
WoundConsulting GmbH Uniklinik Halle/Saale
City
Halle
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Schmidt
Email
diana.schmidt@woundconsulting.com
First Name & Middle Initial & Last Name & Degree
Thomas Wild, MD
Facility Name
Städtisches Klinikum Karlsruhe GmbH
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Pfirmann
Email
christian.pfirmann@klinikum-karlsruhe.de
First Name & Middle Initial & Last Name & Degree
Martin Storck
Facility Name
Krankenhaus Reinbek, St Adolf-Stift GmbH
City
Reinbek
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Bertschat
Email
Sebastian.Bertschat@krankenhaus-reinbek.de
First Name & Middle Initial & Last Name & Degree
Annette Sommerfeld, MD
Facility Name
Klinik und Poliklinik für Dermatologie and Venerologie
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gesine Bandow
Email
Gesine.bandow@med.uni-rostock.de
First Name & Middle Initial & Last Name & Degree
Susen Rode, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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