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Antimicrobial Dressing
Dressings for Venous Leg Ulcers
N/A
Recruiting
Led By Hadar Lev-Tov, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Venous leg ulcer (VLU) is present on the leg. VLU shall be full thickness but without exposure of deeper tissues (muscle bone or tendon)
VLU at least 2 cm2 in size but not larger than 100 cm2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks
Awards & highlights
Study Summary
This trial will test whether Cutimed Sorbact can reduce the bacterial load in venous leg ulcers.
Who is the study for?
Adults with venous leg ulcers present for at least a month, sized 2-100 cm². Participants must not have certain medical conditions like autoimmune diseases or uncontrolled diabetes, and women of childbearing age should use contraception. Ulcers should be treated previously with silver therapy and show no signs of infection.Check my eligibility
What is being tested?
The study is testing the effectiveness of Cutimed Sorbact versus Acticoat in reducing bacterial load in venous leg ulcers. It will involve participants who meet specific health criteria to ensure accurate results on how well these treatments work.See study design
What are the potential side effects?
Potential side effects are not detailed but may include skin reactions or sensitivity due to dressing materials used in treatment. As this trial focuses on wound dressings, systemic side effects are less likely compared to drug interventions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a deep leg ulcer that does not expose muscle or bone.
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My wound is between 2 cm2 and 100 cm2 in size.
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My wound is clean after removing damaged tissue.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in bacterial load
Secondary outcome measures
EQ-5D-5L Quality of life Scores
Incidence of adverse events
Pain
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cutimed® Sorbact®Experimental Treatment1 Intervention
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Group II: Acticoat®Active Control1 Intervention
Participants in this group will receive the Acticoat intervention for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cutimed® Sorbact®
2022
N/A
~210
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
899 Previous Clinical Trials
409,697 Total Patients Enrolled
BSN Medical IncIndustry Sponsor
5 Previous Clinical Trials
844 Total Patients Enrolled
Hadar Lev-Tov, MDPrincipal Investigator - University of Miami
University of Miami Hospital
8 Previous Clinical Trials
195 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with silver-based therapy for my leg ulcer.My ulcer showed signs of infection needing oral antibiotics between my first and second visit.I have a deep leg ulcer that does not expose muscle or bone.A recent ultrasound of the veins in the affected limb shows blood flowing the wrong way for more than half a second.My ulcer is not caused by poor vein function, according to my doctor.My doctor suspects my skin ulcer might be cancerous.I have been on immunosuppressive medications for over 2 weeks in the last month.My ulcer is mostly on my foot.My ulcer size changed by more than 30% after the initial cleaning.I cannot tolerate wearing multiple layers of compression bandages.I am a woman who can have children and agree to use birth control as required.My largest ulcer will be the focus of the study.I have had a study ulcer treated with advanced skin substitutes like Apligraf.My doctor thinks my health condition makes me unsuitable for this study.My leg ulcer has been present for at least one month.My cancer has not been in remission for the past 5 years, except for certain skin cancers or cervical cancer that were successfully treated.My diabetes is not well-managed, with an A1C level over 10%.I am not pregnant, nor am I breastfeeding.I have severe heart failure, with symptoms during rest or moderate exertion.My wound is between 2 cm2 and 100 cm2 in size.Your ankle-brachial pressure index (ABI) is at least 0.80 in the affected leg.My wound is clean after removing damaged tissue.My ulcer has been treated with radiation.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Acticoat®
- Group 2: Cutimed® 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 tally of volunteers for this research endeavor?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial is currently recruiting patients, beginning from its initial posting date of August 22nd 2018 and updated on November 4th 2022. The research team are expecting to have 35 people join the study at one location."
Answered by AI
Are there any available spots for enrolment in this medical research?
"Data found on clinicaltrials.gov suggest that this medical trial is actively sourcing candidates. The first mention of the study was made on August 22nd 2018, and it has since been amended most recently at November 4th 2022."
Answered by AI
What are the projected results of this trial?
"This 8-week clinical trial will evaluate changes in bacterium quantity as its primary aim. Secondary goals include measuring complete healing outome, pain related outcome (as measured by a 10cm VAS scale), and the wound healing rate over 6 weeks of observation."
Answered by AI
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