Silver Dressing for Venous Leg Ulcers

No longer recruiting at 15 trial locations

Overseen By Lisa Teen O'Dwyer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Coloplast A/S

Must not be taking: Antibiotics, Immunosuppressants, Corticoids

Disqualifiers: Pregnancy, Renal insufficiency, Heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of silver dressings, Biatain Ag and Cutimed Siltec Sorbact, to evaluate their effectiveness in healing venous leg ulcers, which are open sores on the leg caused by poor blood flow. Participants will use one of the two dressings for four weeks, then receive standard care for eight weeks, to compare effectiveness. Suitable candidates have had a venous leg ulcer for more than four weeks but less than five years, with wounds at risk of infection. As an unphased trial, this study allows participants to contribute to research that could enhance treatment options for venous leg ulcers.

Do I have to stop taking 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 antibiotics, immunosuppressants, immunomodulating drugs, cytostatic medication, or corticoids (except for certain stable treatments), you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Biatain Ag produces positive results for treating wounds with signs of infection. Patients with slow-healing wounds, such as venous leg ulcers, have tolerated it well. Research indicates significant improvement in wound healing with Biatain Ag, without major safety concerns.

Studies highlight Cutimed Siltec Sorbact's ability to safely manage wound infections. It effectively absorbs wound fluid and reduces the risk of skin damage around the wound. The dressing is designed to keep the wound clean and manage infection without harming patients.

Both treatments have been used in similar wound care situations, demonstrating general safety for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Biatain Ag for venous leg ulcers because it incorporates silver, known for its antimicrobial properties, which can help prevent infections in the wound area. Unlike standard dressings, Biatain Ag releases silver ions continuously, offering sustained protection. In contrast, Cutimed Siltec Sorbact uses a unique Sorbact technology that binds and removes bacteria without relying on chemicals or drugs, potentially reducing the risk of antibiotic resistance. Both treatments offer innovative approaches to managing venous leg ulcers by addressing infection in new ways, which could lead to better healing outcomes.

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

Research has shown that Biatain Ag, one of the treatments tested in this trial, effectively treats venous leg ulcers. Studies indicate it speeds up wound healing and improves recovery rates. A meta-analysis, which combines results from multiple studies, confirmed its superiority over other treatments for quicker healing.

Cutimed Siltec Sorbact, another treatment option in this trial, also shows promise for these ulcers. It employs a special method to reduce bacteria in wounds, aiding in infection prevention and treatment. This supports better healing and has proven effective over many years. Both treatments have strong evidence supporting their ability to heal venous leg ulcers. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

Adults with a venous leg ulcer present for more than 8 weeks but less than 5 years, measuring between 2x2 cm and 10x10 cm, and not deeper than 2 cm. Participants must be able to use compression bandages, have an acceptable level of blood flow in their legs, and show signs of potential infection or high exudate. Excluded are those with exposed bones/tendons, recent immunosuppressive treatments, severe organ failure or allergies to silver/dressing materials.

Inclusion Criteria

If you have diabetes, your HbA1c level should be less than or equal to 10% or 86 mmol/mol in the past 3 months.

I have a long-lasting leg ulcer, but it hasn't been more than 5 years.

My wound is at risk of infection or shows signs like redness, warmth, swelling, pain, or has stopped healing.

Exclusion Criteria

I need dialysis for my kidney problem.

I have a severe inherited immune system disorder.

I have used an anti-microbial dressing on a wound in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to one of two treatment arms with an intervention period of 4 weeks

4 weeks

Standard of Care

Participants receive standard of care treatment for 8 weeks

8 weeks

Follow-up

Participants are monitored for wound healing and quality of life outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Biatain Ag
• Cutimed Siltec Sorbact

Trial Overview The trial is testing two types of silver dressings: Biatain Ag and Cutimed Siltec Sorbact on people with venous leg ulcers. Patients will be randomly assigned to one treatment for four weeks followed by eight weeks standard care to see which dressing better aids wound healing.

How Is the Trial Designed?

Group I: Biatain Ag Experimental Treatment 1 Intervention

Group II: Cutimed Siltec Sorbact Active Control 1 Intervention

Biatain Ag is already approved in European Union, United States for the following indications:

Approved in European Union as Biatain Ag for:

• Venous leg ulcers
• Pressure injuries
• Diabetic foot ulcers
• Superficial and partial-thickness burns
• Donor sites
• Traumatic and post-operative wounds

Approved in United States as Biatain Ag for:

• Moderately to highly exuding leg ulcers
• Pressure injuries
• Diabetic foot ulcers
• Second-degree burns
• Donor sites
• Post-operative wounds
• Skin abrasions

Who Is Running the Clinical Trial?

Coloplast A/S

Lead Sponsor

Trials

155

Recruited

14,800+

Founded

1957

Headquarters

Humlebæk, Denmark

Known For

Intimate Healthcare Solutions

Top Products

Ostomy bags, Continence products, Wound dressings

Kristian Villumsen

Coloplast A/S

Chief Executive Officer since 2018

Master's degree in Political Science from Aarhus University

Preeti Jain

Coloplast A/S

Chief Medical Officer since 2023

MD from University of Copenhagen

Published Research Related to This Trial

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 45 patients with leg ulcers, the absorbent dressing UrgoCell Silver significantly reduced clinical signs of critical colonization, with an average decrease from 3.6 to 1.2 signs per ulcer after four weeks (p < 0.001).

The dressing also led to a mean reduction in ulcer area of 35% and was well tolerated, with only a few minor local side effects reported, indicating both efficacy and safety in managing venous leg ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new silver foam dressing in patients with critically colonised venous leg ulcers. Lazareth, I., Ourabah, Z., Senet, P., et al.[2016]

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]

A meta-analysis of 4 randomized controlled trials involving 685 patients demonstrated that the silver-releasing foam dressing Biatain Ag significantly improves healing rates for hard-to-heal venous leg ulcers compared to non-active dressings.

The use of Biatain Ag resulted in statistically significant treatment effects, with a responder rate and healing rate showing strong evidence (p<0.0001 and p=0.002, respectively) for its efficacy in ulcer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of biatain Ag in hard-to-heal venous leg ulcers: meta-analysis of randomised controlled trials. Leaper, D., Münter, C., Meaume, S., 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]

In a study involving 213 patients, silver-donating dressings did not show a significant difference in healing rates compared to non-silver low-adherence dressings for venous leg ulcers after 12 weeks, with healing rates of 59.6% and 56.7% respectively.

The cost-effectiveness analysis revealed that the antimicrobial dressings had a high incremental cost-effectiveness ratio of £489,250 per quality-adjusted life year, indicating that there is no strong economic justification for their routine use in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial and cost-effectiveness analysis of silver-donating antimicrobial dressings for venous leg ulcers (VULCAN trial). Michaels, JA., Campbell, B., King, B., et al.[2021]

In a study involving 181 patients with venous leg ulcers, the silver-releasing dressing Biatain-Ag demonstrated superior wound area reduction compared to the non-silver dressing Biatain after 6 weeks of treatment.

Biatain-Ag continued to show effectiveness even 4 weeks after treatment ended, particularly benefiting patients with poor healing prognosis, such as older individuals with larger, longer-lasting ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of a silver-releasing foam dressing in venous leg ulcer healing: a randomised controlled trial. Senet, P., Bause, R., Jørgensen, B., et al.[2021]

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]

In a study involving 129 patients and 150 wounds, the use of Cutimed® Siltec® and Cutimed Siltec B dressings significantly reduced wound exudate and pain during dressing changes, indicating their effectiveness in wound management.

Both clinicians and patients reported high satisfaction with the dressings, rating their comfort, ease of use, and absorption capabilities as 'good' to 'very good', highlighting their potential for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicentre, observational evaluation of the product characteristics of two absorbent foam dressings. Seckam, A.[2019]

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]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK153568/

The use of biatain Ag in hard-to-heal venous leg ulcers - NCBI RESULTS: Biatain Ag showed a significant treatment effect (p<0.0001), responder rate (p<0.001), and healing rate (p = 0.002).

2. coloplastprofessional.co.uk coloplastprofessional.co.uk/globalassets/hcp/coloplast-professional/wound-care-pages/doncaster/biatain-silver_monograph.pdf

Biatain® Silicone Ag & Biatain® Ag Monograph The meta-analysis provides statistical significant evidence to support the use of Biatain Ag for treatment of venous leg ulcers, showing faster healing compared ...

3. researchgate.net researchgate.net/publication/248398192_The_Use_of_Biatain_Ag_in_Hard-to-Heal_Venous_Leg_Ulcers_Meta-Analysis_of_Randomised_Controlled_Trials

The Use of Biatain Ag in Hard-to-Heal Venous Leg Ulcers Biatain Ag showed a significant treatment effect (p<0.0001), responder rate (p<0.001), and healing rate (p = 0.002). The meta-analysis of the 4 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00627094

Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2213333X2100305X

Topical Treatment for Venous Leg Ulcers: Evidence Review Two thirds of VLUs will heal with compression therapy only according to the ESCHAR (effect of surgery and compression on healing and recurrence) trial. The ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15045807/

Safety and Performance of a New Non-Adhesive Foam ... This study demonstrates that treatment of diabetic foot ulcers with Biatain Non-adhesive Dressing results in considerable wound area reduction.

7. researchgate.net researchgate.net/publication/321533067_Safety_and_performance_of_a_new_non-adhesive_foam_dressing_for_the_treatment_of_diabetic_foot_ulcers

Safety and performance of a new non-adhesive foam ... The mean wound area reduced from 5.4 cm2 to 2.5 cm2. Relative wound area reduced from 100% at baseline to 40% at week 6. 'Wearing comfort' ...