The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05923749
Recruitment Status : **RECRUITING NOW**
First Posted : June 28, 2023
Last Update Posted : June 28, 2023
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
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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.
Wound Heal
Device: Biatain Ag Device: Cutimed Siltec Sorbact
Not Applicable
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Study Type :
Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date :
June 2023
Estimated Primary Completion Date :
October 31, 2024
Estimated Study Completion Date :
October 31, 2024
Resource links provided by the National Library of Medicine
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Experimental: Biatain Ag
Device: Biatain Ag
Biatain with silver
Active Comparator: Cutimed Siltec Sorbact
Device: Cutimed Siltec Sorbact
comparator device
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Primary Outcome Measures :
Wound healing [ Time Frame: After 4 weeks ]
Relative wound area change measured by calculation of area based on photo of wound
Secondary Outcome Measures :
Wound area reduction [ Time Frame: After 4 weeks ]
Reaching ≥ 40% wound area change
Wound healing [ Time Frame: After 12 weeks ]
Wounds healed after 12 weeks (yes/no assessed by investigator)
Quality of Life (based on Wound-Quality of Life-17 questionnaire) [ Time Frame: After 4 and 12 weeks ]
Patient Quality of Life
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Ages Eligible for Study: Â
18 Years and older  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
No
Inclusion Criteria:
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
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05923749
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Detroit foot and ankle Specialists
Clinton Township, Michigan, United States, 48038
Contact: Brian Loder     bloder@detroitfa.com  Â
Serena Group
Monroeville, Pennsylvania, United States, 15146
Contact: Meghan Neil     mneil@serenagroups.com  Â
Coloplast A/S
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Responsible Party:
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT05923749 Â Â
Other Study ID Numbers:
CP354
First Posted:
June 28, 2023 Â Â Key Record Dates
Last Update Posted:
June 28, 2023
Last Verified:
June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
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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:
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Varicose UlcerLeg UlcerSkin UlcerSkin Diseases
Varicose VeinsVascular DiseasesCardiovascular Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
