VLU Dressing Study

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

Official Title
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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)

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Device: Cutimed® Sorbact®
* Device: Acticoat®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cutimed® Sorbact®<br>Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks. | Device: Cutimed® Sorbact®<br>* Dialkylcarbomoyl chloride based wound dressing<br>|
| Active Comparator: Acticoat®<br>Participants in this group will receive the Acticoat intervention for 6 weeks. | Device: Acticoat®<br>* Silver impregnated contact layer dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bacterial load | 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 | Wound healing rate (in cm^2/week) will be calculated by measuring the wound area | 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 | 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) | 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. | 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. | Up to 8 weeks | 
| Incidence of adverse events | As assessed by treating physician | Up to 8 weeks |