VLU Dressing Study

NCT03621592 | Completed Results FDA Device

• 1 other identifier: 20180468
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Change in Bacterial Load

  Mean change in bacterial load in Colony Forming Units (CFU)/grams will be assessed from tissue samples

  Baseline, Up to 8 weeks

Secondary Outcomes (6)

• Wound Healing Rate

  Up 6 weeks

• Percentage of Subjects With Complete Healing

  Up to 8 weeks

• Pain as Measured by VAS Scores

  Up to 8 weeks

• Wound Quality of Life (WQoL) Scores

  Up to 8 weeks

• EQ-5D-5L Quality of Life Scores

  Up to 8 weeks

Study Arms (2)

Cutimed® Sorbact®

EXPERIMENTAL

Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.

Device: Cutimed® Sorbact®

Acticoat®

ACTIVE COMPARATOR

Participants in this group will receive the Acticoat intervention for 6 weeks.

Device: Acticoat®

Interventions

Cutimed® Sorbact® DEVICE

Dialkylcarbomoyl chloride based wound dressing

Cutimed® Sorbact®

Acticoat® DEVICE

Silver impregnated contact layer dressing

Acticoat®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• University of Miami: lead
• BSN Medical Inc: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Hadar Lev-Tov, MD
• Organization: University of Miami

hlevtov@med.miami.edu

305-243-4472

Study Officials

• Hadar Lev-Tov, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the study and products, investigator blinding is unrealistic and subject blinding is unlikely. Research staff will avoid naming the dressing or suggesting the assignment to the subjects. However, an independent monitor with experience in treating wounds will be blinded to the treatment assignment and will confirm healing outcomes based on images.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 8, 2018
• Study Start: August 22, 2018
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)