- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03621592
VLU Dressing Study
January 26, 2024 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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
35
Phase
- 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
- Name: Aliette Espinosa
- Phone Number: 305-689-3376
- Email: a.espinosa2@med.miami.edu
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- Recruiting
- University of Miami
-
Contact:
- Aliette Espinosa
- Phone Number: 305-689-3376
- Email: a.espinosa2@med.miami.edu
-
Principal Investigator:
- Hadar Lev-Tov, MD
-
-
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
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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).
- 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.
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 |
Intervention / Treatment |
---|---|
Experimental: Cutimed® Sorbact®
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
|
Dialkylcarbomoyl chloride based wound dressing
|
Active Comparator: Acticoat®
Participants in this group will receive the Acticoat intervention for 6 weeks.
|
Silver impregnated contact layer dressing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in bacterial load
Time Frame: Baseline, Up to 8 weeks
|
Bacterial load in Colony Forming Units (CFU)/grams will be assessed from tissue samples
|
Baseline, Up to 8 weeks
|
Secondary Outcome Measures
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)
|
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.
|
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".
|
Up to 8 weeks
|
Incidence 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
Collaborators
Investigators
- 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)
August 22, 2018
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
July 20, 2018
First Submitted That Met QC Criteria
August 3, 2018
First Posted (Actual)
August 8, 2018
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 26, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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