Venous Leg UlcerNCT03621592
VLU Dressing Study
A study testing Cutimed® Sorbact® and Acticoat® in people with Venous Leg Ulcer, run by University of Miami at 1 site in United States.
Trial summary
The goal of the study is to investigate the effectiveness of Cutimed Sorbact (Study Device) in modifying bacterial load in venous leg ulcers (VLU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Cutimed® Sorbact® and Acticoat®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2018to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, 18 years old and older (i.e. age ≥ 18 years).
- Venous leg ulcer (VLU) is present on the leg. VLU shall be full thickness but without exposure of deeper tissues (muscle bone or tendon).
- If more than one ulcer is present, the largest ulcer meeting criteria shall be designated the study ulcer.
- If more than one ulcer on the study ulcer limb, study ulcer shall be at least one centimeter from other ulcers.
- Venous Doppler ultrasound exam, within one year from randomization, shall demonstrate reflux of over 0.5 seconds in the affected limb.
- Ankle-Brachial Pressure Index (ABI) exam with value of ≥0.80 in the affected limb
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- VLU has been treated with silver based therapy for at least 2 weeks within the previous 6 months.
- VLU present for at least one month prior to screening visit 1.
- VLU at least 2 cm2 in size but not larger than 100 cm2.
- After debridement, study ulcer demonstrates a clean wound bed.
- 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.
- Subject is able to comprehend all study related procedures and adhere to study schedule.
- Subject is able to provide written informed consent.
Who cannot join
- Based on investigator medical judgment, ulcer is caused by any etiology exclusive of venous insufficiency.
- 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.
- Study Ulcer exhibits clinical signs and symptoms of infection in the period between screening visit 1 and treatment visit 1 requiring oral antibacterial therapy.
- Subject has known allergy to any of the materials used in the study.
- Subject is unable to tolerate multi-layer compression therapy.
- Based on investigator medical judgment, the Study Ulcer is suspicious for cancer (e.g. basal cell carcinoma or squamous cell carcinoma).
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- 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.
- In the month prior to screening visit 1 subject was enrolled in any other research protocol for treatment of Study Ulcer.
- 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).
- Study ulcer area has been treated with radiation therapy at any time.
- 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.
- 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).
- Subject is diagnosed with New York Heart Association Class III and IV congestive heart.
- Failure: Class III: Symptoms with moderate exertion or, Class IV: Symptoms at rest.
- Subject is diagnosed with diabetes mellitus that is poorly controlled and shall be defined as hemoglobin A1C >10%.
- Study Ulcer is completely or more than 50% of the Study Ulcer is located on the foot (i.e. below the malleolus).
- 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.
- Positive pregnancy test in screening visit 1 in a female of childbearing potential or active pregnancy or breast-feeding.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Venous Leg Ulcer
- Being tested
- Cutimed® Sorbact®, Acticoat®
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutimed® Sorbact®Device
Dialkylcarbomoyl chloride based wound dressing
Acticoat®Device
Silver impregnated contact layer dressing
| Study group | Role | What they receive |
|---|---|---|
| Cutimed® Sorbact® | Experimental | Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks. Receives: Device: Cutimed® Sorbact® |
| Acticoat® | Active comparator | Participants in this group will receive the Acticoat intervention for 6 weeks. Receives: Device: Acticoat® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bacterial Load
Mean change in bacterial load in Colony Forming Units (CFU)/grams will be assessed from tissue samples
Measured: Baseline, Up to 8 weeks
Secondary outcomes (6)
Wound Healing Rate
Wound healing rate (in cm^2/week) will be calculated by measuring the wound area
Measured: Up 6 weeks
Percentage of Subjects With Complete Healing
The percentage of subjects achieving complete healing of ulcer at the evaluation of treating physician will be reported
Measured: Up to 8 weeks
Pain as Measured by VAS Scores
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.
Measured: Up to 8 weeks
Wound Quality of Life (WQoL) Scores
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.
Measured: Up to 8 weeks
EQ-5D-5L Quality of Life Scores
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.
Measured: Up to 8 weeks
Number of Adverse Events
As assessed by treating physician
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start22 Aug 2018
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- BSN Medical Inc
- Responsible party
- Principal investigator, Hadar Lev-Tov, University of Miami
- Investigators
- Hadar Lev-Tov, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621592
- Sponsor's protocol ID
- 20180468
- Status last verified
- Aug 2025
- First submitted
- 20 Jul 2018
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03621592
- Acronym / sponsor ID
- 20180468
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- BSN Medical Inc
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cutimed® Sorbact® | Experimental | Device: Cutimed® Sorbact®Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks. |
| Acticoat® | Active comparator | Device: Acticoat®Participants in this group will receive the Acticoat intervention for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults, 18 years old and older (i.e. age ≥ 18 years).
- Venous leg ulcer (VLU) is present on the leg. VLU shall be full thickness but without exposure of deeper tissues (muscle bone or tendon).
- If more than one ulcer is present, the largest ulcer meeting criteria shall be designated the study ulcer.
- If more than one ulcer on the study ulcer limb, study ulcer shall be at least one centimeter from other ulcers.
- Venous Doppler ultrasound exam, within one year from randomization, shall demonstrate reflux of over 0.5 seconds in the affected limb.
Key exclusion criteria (19 listed)
- Based on investigator medical judgment, ulcer is caused by any etiology exclusive of venous insufficiency.
- 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.
- Study Ulcer exhibits clinical signs and symptoms of infection in the period between screening visit 1 and treatment visit 1 requiring oral antibacterial therapy.
- Subject has known allergy to any of the materials used in the study.
- Subject is unable to tolerate multi-layer compression therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cutimed® Sorbact®Dialkylcarbomoyl chloride based wound dressing | Device | Cutimed® Sorbact® |
| Acticoat®Silver impregnated contact layer dressing | Device | Acticoat® |
Primary outcome
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
6 secondary outcomes
Wound Healing Rate
Time frame: Up 6 weeks
Percentage of Subjects With Complete Healing
Time frame: Up to 8 weeks
Pain as Measured by VAS Scores
Time frame: Up to 8 weeks
Wound Quality of Life (WQoL) Scores
Time frame: Up to 8 weeks
EQ-5D-5L Quality of Life Scores
Time frame: Up to 8 weeks
Number of Adverse Events
Time frame: Up to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
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A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
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Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadar Lev-Tov, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cutimed® Sorbact® and Acticoat® in people with Venous Leg Ulcer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bacterial Load (time frame: Baseline, Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.