VLU Dressing Study

August 25, 2025 updated by: Hadar Lev-Tov, University of Miami

An Exploratory, Single Center, Observer Masked, Active Control, Randomized Trial to Investigate the Effectiveness of Dialkylcarbomoyl Chloride Dressing (Cutimed Sorbact) in Modifying Bacterial Load in Venous Leg Ulcers (VLU)

The goal of the study is to investigate the effectiveness of Cutimed Sorbact (Study Device) in modifying bacterial load in venous leg ulcers (VLU).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults, 18 years old and older (i.e. age ≥ 18 years).
  2. Venous leg ulcer (VLU) is present on the leg. VLU shall be full thickness but without exposure of deeper tissues (muscle bone or tendon).
  3. If more than one ulcer is present, the largest ulcer meeting criteria shall be designated the study ulcer.
  4. If more than one ulcer on the study ulcer limb, study ulcer shall be at least one centimeter from other ulcers.
  5. Venous Doppler ultrasound exam, within one year from randomization, shall demonstrate reflux of over 0.5 seconds in the affected limb.
  6. Ankle-Brachial Pressure Index (ABI) exam with value of ≥0.80 in the affected limb
  7. VLU has been treated with silver based therapy for at least 2 weeks within the previous 6 months.
  8. VLU present for at least one month prior to screening visit 1.
  9. VLU at least 2 cm2 in size but not larger than 100 cm2.
  10. After debridement, study ulcer demonstrates a clean wound bed.
  11. If subject is a female of childbearing potential, subject must use at least one method of contraception acceptable by PI such as birth control pills, Intrauterine Device (IUD), condoms, or sexual abstinence. At visit 1 urine pregnancy test must be negative.
  12. Subject is able to comprehend all study related procedures and adhere to study schedule.
  13. Subject is able to provide written informed consent.

Exclusion Criteria:

  1. Based on investigator medical judgment, ulcer is caused by any etiology exclusive of venous insufficiency.
  2. Study Ulcer surface area (post-debridement) has increased or decreased by more than 30% in the period between screening visit 1 and treatment visit 1.
  3. Study Ulcer exhibits clinical signs and symptoms of infection in the period between screening visit 1 and treatment visit 1 requiring oral antibacterial therapy.
  4. Subject has known allergy to any of the materials used in the study.
  5. Subject is unable to tolerate multi-layer compression therapy.
  6. Based on investigator medical judgment, the Study Ulcer is suspicious for cancer (e.g. basal cell carcinoma or squamous cell carcinoma).
  7. In the month prior to screening visit 1 subject was treated with systemic immunosuppressive medications for more than 2 weeks (e.g. chemotherapy, corticosteroids), and/or it is anticipated subject will require such medications during study period.
  8. In the month prior to screening visit 1 subject was enrolled in any other research protocol for treatment of Study Ulcer.
  9. The Subject has been diagnosed with malignant disease not in remission over the 5 years immediately preceding screening visit 1. (Except: cervical carcinoma in situ, cutaneous squamous cell carcinoma, cutaneous basal cell carcinoma that have been treated and have no evidence of recurrence or metastases).
  10. Study ulcer area has been treated with radiation therapy at any time.
  11. In the opinion of PI the subject has a medical condition such as autoimmune, renal, hepatic or hematologic disease that makes the subject an inappropriate candidate for participation in study.
  12. In the month preceding screening visit 1 Study Ulcer has been treated with advanced tissue engineered devices matrix based devices (e.g., Apligraf, Dermagraft, Oasis).
  13. Subject is diagnosed with New York Heart Association Class III and IV congestive heart.
  14. Failure: Class III: Symptoms with moderate exertion or, Class IV: Symptoms at rest.
  15. Subject is diagnosed with diabetes mellitus that is poorly controlled and shall be defined as hemoglobin A1C >10%.
  16. Study Ulcer is completely or more than 50% of the Study Ulcer is located on the foot (i.e. below the malleolus).
  17. Subject is a female of childbearing potential, and refusing to use at least one method of contraception acceptable by PI such as birth control pills, IUD, condoms, or sexual abstinence.
  18. Positive pregnancy test in screening visit 1 in a female of childbearing potential or active pregnancy or breast-feeding.
  19. In the opinion of the PI the subject is unable to understand or comply with study related protocol including but not limited to providing informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cutimed® Sorbact®
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Device: Cutimed® Sorbact®
Dialkylcarbomoyl chloride based wound dressing
Active Comparator: Acticoat®
Participants in this group will receive the Acticoat intervention for 6 weeks.
Device: Acticoat®
Silver impregnated contact layer dressing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Bacterial Load
Time Frame: Baseline, Up to 8 weeks
Mean change in bacterial load in Colony Forming Units (CFU)/grams will be assessed from tissue samples
Baseline, Up to 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wound Healing Rate
Time Frame: Up 6 weeks
Wound healing rate (in cm^2/week) will be calculated by measuring the wound area
Up 6 weeks
Percentage of Subjects With Complete Healing
Time Frame: Up to 8 weeks
The percentage of subjects achieving complete healing of ulcer at the evaluation of treating physician will be reported
Up to 8 weeks
Pain as Measured by VAS Scores
Time Frame: Up to 8 weeks
The Pain Visual Analog Scale (VAS) has range from 0 (no pain) to 100 (worst possible pain). Mean change in scores will be reported from last visit compared to baseline will be reported.
Up to 8 weeks
Wound Quality of Life (WQoL) Scores
Time Frame: Up to 8 weeks
WQoL is a 17 item questionnaire with each question scored on a 5 point scale, where 0 is "not at all" and 5 is "very much". WQoL has a total score ranging from 0 to 85 with a lower score indicating better quality of life. Mean change in scores will be reported from last visit compared to baseline will be reported.
Up to 8 weeks
EQ-5D-5L Quality of Life Scores
Time Frame: Up to 8 weeks
The Euro Quality of life-5-Dimension-5-Level (EQ-5D-5L) is averaged based off the 5 point scale, where 0 is "no problems" and 5 is "extreme problems". Difference in scores will be reported from last visit compared to baseline will be reported.
Up to 8 weeks
Number of Adverse Events
Time Frame: Up to 8 weeks
As assessed by treating physician
Up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BSN Medical Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hadar Lev-Tov, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 22, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20180468

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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