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Silver Dressing
Silver Dressing for Venous Leg Ulcers
N/A
Recruiting
Research Sponsored by Coloplast A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 acceptance of compression bandages
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 4 and 12 weeks
Awards & highlights
Study Summary
This trial will investigate the healing of venous leg ulcers over 4 weeks in 178 patients, divided into two treatment groups.
Who is the study for?
Adults with a venous leg ulcer present for more than 8 weeks but less than 5 years, measuring between 2x2 cm and 10x10 cm, and not deeper than 2 cm. Participants must be able to use compression bandages, have an acceptable level of blood flow in their legs, and show signs of potential infection or high exudate. Excluded are those with exposed bones/tendons, recent immunosuppressive treatments, severe organ failure or allergies to silver/dressing materials.Check my eligibility
What is being tested?
The trial is testing two types of silver dressings: Biatain Ag and Cutimed Siltec Sorbact on people with venous leg ulcers. Patients will be randomly assigned to one treatment for four weeks followed by eight weeks standard care to see which dressing better aids wound healing.See study design
What are the potential side effects?
Potential side effects may include skin irritation or allergic reactions at the site of the dressing application due to sensitivity towards silver or other ingredients in the dressings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My wound is at risk of infection or shows signs like redness, warmth, swelling, pain, or has stopped healing.
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I am okay with wearing compression bandages.
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My wound is between 2x2 cm and 10x10 cm in size.
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My wound is no deeper than 2 cm.
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I am over 18 and can legally make my own decisions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 4 and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 4 and 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Quality of Life (based on Wound-Quality of Life-17 questionnaire)
Wound area reduction
Wound healing
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Biatain AgExperimental Treatment1 Intervention
Group II: Cutimed Siltec SorbactActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biatain Ag
2008
N/A
~190
Find a Location
Who is running the clinical trial?
Coloplast A/SLead Sponsor
152 Previous Clinical Trials
14,491 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have diabetes, your HbA1c level should be less than or equal to 10% or 86 mmol/mol in the past 3 months.I have a long-lasting leg ulcer, but it hasn't been more than 5 years.I need dialysis for my kidney problem.My wound is at risk of infection or shows signs like redness, warmth, swelling, pain, or has stopped healing.I have a severe inherited immune system disorder.I have used an anti-microbial dressing on a wound in the last 2 weeks.I am okay with wearing compression bandages.My wound exposes tendons, bones, or has deep openings.I have not taken steroids, immunosuppressants, or cancer drugs in the last 4 weeks.You are allergic to silver or other materials used for wound dressings, including compression therapy.My wound leaks a moderate to high amount but doesn't need more than 1 dressing change a day.More than half of my wound is dead tissue.My wound is between 2x2 cm and 10x10 cm in size.I have severe heart failure.My wound is no deeper than 2 cm.I am over 18 and can legally make my own decisions.I can follow the study's skin care routine using salt water and dressing.I am currently on antibiotics or have been in the last 2 weeks.I have a blood disorder.You have a healthy ankle-brachial pressure and, if you have diabetes, a normal Doppler signal in your ankle.
Research Study Groups:
This trial has the following groups:- Group 1: Biatain Ag
- Group 2: Cutimed Siltec Sorbact
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment size for this investigation?
"Affirmative, information available from clinicaltrials.gov confirms that this research endeavor is presently enrolling participants. It was initially advertised on June 1st 2023 and subsequently updated on the 27th of June in the same year. A total of 178 individuals are required between two different medical sites."
Answered by AI
Are there any openings left in this clinical experiment?
"Affirmative. Clinicaltrials.gov verifies that this research initiative, which was first made public on June 1st 2023, is actively recruiting candidates. The study necessitates 178 patients from 2 distinct medical centres."
Answered by AI
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