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

35 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial investigates if Cutimed Sorbact, a special wound dressing, can reduce bacteria in venous leg ulcers. It targets patients with these hard-to-heal wounds by using a dressing that attracts and removes bacteria to promote healing. Cutimed Sorbact is an absorbent bacteria-binding foam dressing used in wound healing and has been studied for its impact on patients' quality of life.

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 data supports the effectiveness of the treatment Cutimed Siltec Sorbact for venous leg ulcers?

Research shows that Cutimed Siltec Sorbact dressings are effective in managing venous leg ulcers by absorbing wound fluid, reducing infection, and improving the surrounding skin condition, which also positively impacts patients' quality of life. ^{1 2 3 4 5}

Is the dressing safe for use in humans?

The Cutimed Sorbact range of dressings is considered safe for long-term use with minimal risk of side effects, as it binds bacteria to its surface for removal without killing them. ^{1 2 3 4 6}

How does the treatment Cutimed Sorbact differ from other treatments for venous leg ulcers?

Cutimed Sorbact is unique because it uses a hydrophobic (water-repelling) fatty acid coating to bind and remove bacteria from wounds, which helps manage infections without relying on traditional antimicrobial agents like silver. This approach can improve wound healing and patient comfort by effectively absorbing wound exudate (fluid) and reducing infection-related complications. ^{1 2 3 4 7}

Research Team

Hadar Lev-Tov, MD

Principal Investigator

University of Miami

Eligibility Criteria

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.

Subject is able to comprehend all study related procedures and adhere to study schedule

I have a deep leg ulcer that does not expose muscle or bone.

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.

My ulcer is not caused by poor vein function, according to my doctor.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical performance and quality of life impact of an absorbent bacteria-binding foam dressing. [2021]

2. England 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). [2023]

3. England pubmed.ncbi.nlm.nih.gov

Innovative solutions to daily challenges. [2010]

4. England pubmed.ncbi.nlm.nih.gov

Hydrogel-impregnated dressings for graft fixation: a case series. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Dialkylcarbamoyl chloride (DACC)-coated dressings in the management and prevention of wound infection: a systematic review. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Czech Republic pubmed.ncbi.nlm.nih.gov

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