Dressings for Venous Leg Ulcers

Overseen By Aliette Espinosa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must be taking: Silver based therapy

Must not be taking: Immunosuppressives, Antibacterials

Disqualifiers: Cancer, Heart failure, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a special dressing, Cutimed Sorbact, in reducing bacteria in venous leg ulcers. Venous leg ulcers are painful sores on the leg caused by poor blood flow. Participants will receive either the Cutimed Sorbact dressing or a comparison treatment called Acticoat, a silver-based dressing, for six weeks. The trial seeks individuals who have had a venous leg ulcer for at least a month, are currently managing it with silver-based therapy, and have a clean wound bed after cleaning. As an unphased trial, this study provides a unique opportunity to contribute to understanding new treatment options for venous leg ulcers.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive medications, you may not be eligible to participate.

What prior data suggests that this study device is safe for venous leg ulcers?

Research has shown that Cutimed Sorbact is safe and easy to use. Studies have found that it reduces bacteria in wounds without causing harm. This dressing manages infections by adhering to bacteria. It is effective against many common germs, including those that are hard to treat. Previous reports have not indicated any major side effects, suggesting it is generally a safe choice for treating wounds. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Cutimed Sorbact for venous leg ulcers because it offers a unique approach to wound care. Unlike traditional treatments that often rely on antibiotics or chemical agents, Cutimed Sorbact uses a physical mechanism to bind and remove bacteria from the wound. This reduces the risk of antibiotic resistance and can promote faster healing by keeping the ulcer environment clean without introducing additional chemicals. This innovative method provides a promising alternative to more conventional options like silver dressings or hydrocolloid dressings.

What evidence suggests that this trial's treatments could be effective for venous leg ulcers?

Research has shown that Cutimed Sorbact, one of the treatments in this trial, effectively reduces bacteria in wounds, including venous leg ulcers (VLUs). Sorbact dressings capture and remove bacteria, aiding wound healing and lowering infection risk. Studies have found it can be more effective than silver dressings in reducing bacteria, making it a strong choice for controlling infections in persistent wounds.

Acticoat, another dressing compared in this trial, also protects against bacteria. It uses a silver coating to quickly kill bacteria and prevent infections. Both treatments aim to reduce bacteria to aid healing, but Sorbact has shown particular promise in managing infections in chronic wounds. ^{6 7 8 9 10}

Who Is on the Research Team?

Hadar Lev-Tov, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

Adults with venous leg ulcers present for at least a month, sized 2-100 cm². Participants must not have certain medical conditions like autoimmune diseases or uncontrolled diabetes, and women of childbearing age should use contraception. Ulcers should be treated previously with silver therapy and show no signs of infection.

Inclusion Criteria

I have been treated with silver-based therapy for my leg ulcer.

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

Exclusion Criteria

Subject has known allergy to any of the materials used in the study

My ulcer showed signs of infection needing oral antibiotics between my first and second visit.

I have been on immunosuppressive medications for over 2 weeks in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Acticoat or Cutimed Sorbact intervention for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acticoat
• Cutimed Sorbact

Trial Overview

The study is testing the effectiveness of Cutimed Sorbact versus Acticoat in reducing bacterial load in venous leg ulcers. It will involve participants who meet specific health criteria to ensure accurate results on how well these treatments work.

How Is the Trial Designed?

Group I: Cutimed® Sorbact® Experimental Treatment 1 Intervention

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

Group II: Acticoat® Active Control 1 Intervention

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

Cutimed Sorbact is already approved in European Union, United States for the following indications:

Approved in European Union as Cutimed Sorbact for:

• Venous leg ulcers
• Diabetic foot ulcers
• Pressure ulcers
• Chronic wounds

Approved in United States as Cutimed Sorbact for:

• Venous leg ulcers
• Diabetic foot ulcers
• Pressure ulcers
• Chronic wounds

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

BSN Medical Inc

Industry Sponsor

Trials

6

Recruited

880+

Published Research Related to This Trial

The Cutimed Sorbact range uses DACC technology to bind pathogens instead of killing them, allowing for safe removal during dressing changes.

This method enables long-term use of the dressings with minimal risk of side effects, making it a safer option compared to traditional antimicrobial dressings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe, long-term management of bioburden that helps promote healing Evidence review of DACC technology. Cutting, K., McGuire, J.[2015]

In a study involving seven patients aged 23 to 86, the use of hydrogel-impregnated dressings for skin graft fixation resulted in no infections, demonstrating their effectiveness in preventing graft loss.

These dressings not only provide antibacterial properties by binding to bacteria but also keep the wound moist, offering advantages over traditional petrolatum or paraffin gauze dressings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrogel-impregnated dressings for graft fixation: a case series. Choi, JS., Lee, JH., Kim, SM., et al.[2015]

DACC-coated dressings have been shown to effectively reduce bacterial load at wound surfaces and may lower the rates of postoperative surgical site infections, based on a systematic review of 17 studies involving 3408 patients.

While the evidence is still limited, DACC-coated dressings appear to improve the appearance of chronic wounds and manage infections without causing adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialkylcarbamoyl chloride (DACC)-coated dressings in the management and prevention of wound infection: a systematic review. Totty, JP., Bua, N., Smith, GE., et al.[2022]

The article discusses the importance of selecting the right combination of wound dressings to effectively manage complex wounds, emphasizing the need for moisture retention and exudate control to reduce complications.

It highlights the clinical evaluations of new antimicrobial and exudate management dressings, specifically Cutimed® Sorbact®, Cutimed® Siltec®, and Cutisorb® Ultra, as promising tools in improving wound care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative solutions to daily challenges. Derbyshire, A.[2010]

Current treatments for leg ulcers are evolving from traditional methods like ointments and compresses to advanced dressings that are based on modern wound healing science, including hydrogels and alginate dressings.

The choice of dressing must be tailored to the specific type and stage of the ulcer, as each type of dressing has unique properties and effects, emphasizing the importance of personalized treatment in promoting healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A new generation of dressings in the treatment of leg ulcers]. Pospísilová, A.[2006]

In a study involving 62 patients with venous leg ulcers or diabetic foot ulcers, the Cutimed® Siltec® Sorbact® dressing significantly improved wound management by effectively absorbing exudate and reducing infection rates, with a 9% decrease in infected wounds observed after 28 days.

Patients reported high satisfaction with the dressing's comfort and application, and there were notable improvements in the quality of life related to wound infection perception, indicating that this dressing not only aids in healing but also enhances patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical performance and quality of life impact of an absorbent bacteria-binding foam dressing. Seckam, AM., Twardowska-Saucha, K., Heggemann, J., et al.[2021]

This study aims to compare the effectiveness of a hydrophobic dressing (Cutimed Sorbact®) against a silver dressing (Aquacel® Ag Extra) in reducing bacterial colonization in chronic venous leg ulcers, involving 204 participants over a 12-week period.

Hydrophobic dressings may help prevent biofilm formation and reduce antimicrobial resistance, potentially leading to better healing outcomes and improved quality of life for patients with chronic venous leg ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a hydrophobic dressing for microorganisms' colonization of vascular ulcers: Protocol for a randomized controlled trial (CUCO-UV Study). Morilla-Herrera, JC., Morales-Asencio, JM., Gómez-González, AJ., et al.[2023]

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ACTICOAT FLEX 7 Dressings release sufficient silver to remain active for up to 7 days,23-25 potentially creating nursing time and budgetary efficiencies.

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ACTICOAT Flex 3 Silver Dressing 4" x 8" (Each) # ...

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ACTICOAT Surgical Dressings feature a silver-coated polyurethane layer, a white polyurethane foam pad and an adhesive-coated waterproof polyurethane film layer.

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ACTICOAT* Flex 3 is indicated as an antimicrobial barrier for management of partial- and full-thickness wounds including pressure injuries, venous ulcers, ...

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Advanced Wound Care for Hard-to-Heal Wounds

Better patient outcomes with Cutimed. Hard-to-heal wounds, such as ulcers from ischemia, diabetes, venous stasis disease, or pressure, are challenging and ...