What side effects are associated with this type of intervention?

The most common treatments for Venous Leg Ulcers (VLUs) include compression therapy, wound dressings, and debridement. Treatments like Cutimed Sorbact, which physically bind and remove bacteria, generally have minimal side effects. However, patients may experience mild skin irritation or allergic reactions to the dressing materials. Compression therapy can sometimes cause discomfort, skin irritation, or even exacerbate existing skin conditions if not applied correctly. Debridement, while effective in removing dead tissue, can be painful and may lead to minor bleeding or infection if not performed under sterile conditions.

What prior FDA approvals exist?

The FDA has approved various treatments for Venous Leg Ulcers, including advanced wound dressings and topical agents. While specific approvals for treatments that physically bind and remove bacteria, like Cutimed Sorbact, are not detailed in the provided context, similar approaches often involve antimicrobial dressings and negative pressure wound therapy. These treatments aim to reduce bacterial load and promote healing by physically removing bacteria from the wound site.

What other types of research exist?

Promising novel alternatives to Cutimed Sorbact for VLU patients include: 1) Advanced wound dressings such as those incorporating antimicrobial agents like silver or honey, which have shown effectiveness in reducing bacterial load. 2) Negative pressure wound therapy (NPWT), which promotes healing by applying controlled suction to the wound. 3) Bioengineered skin substitutes, which provide a scaffold for new tissue growth and can be combined with antimicrobial properties. 4) Topical oxygen therapy, which enhances wound healing by increasing oxygen availability to the tissue. 5) Low-level laser therapy (LLLT), which has been reported to improve wound healing and reduce infection.

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Antimicrobial Dressing

Dressings for Venous Leg Ulcers

N/A

Recruiting

Led By Hadar Lev-Tov, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Venous leg ulcer (VLU) is present on the leg. VLU shall be full thickness but without exposure of deeper tissues (muscle bone or tendon)

VLU at least 2 cm2 in size but not larger than 100 cm2

Must not have

Study Ulcer is completely or more than 50% of the Study Ulcer is located on the foot (i.e. below the malleolus)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed but may include skin reactions or sensitivity due to dressing materials used in treatment. As this trial focuses on wound dressings, systemic side effects are less likely compared to drug interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My wound is between 2 cm2 and 100 cm2 in size.

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My wound is clean after removing damaged tissue.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My ulcer is mostly on my foot.

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My ulcer size changed by more than 30% after the initial cleaning.

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I cannot tolerate wearing multiple layers of compression bandages.

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I have had a study ulcer treated with advanced skin substitutes like Apligraf.

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I am a woman who can have children and agree to use birth control as required.

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My cancer has not been in remission for the past 5 years, except for certain skin cancers or cervical cancer that were successfully treated.

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My diabetes is not well-managed, with an A1C level over 10%.

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I am not pregnant, nor am I breastfeeding.

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I have severe heart failure, with symptoms during rest or moderate exertion.

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My ulcer has been treated with radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in bacterial load

Secondary study objectives

EQ-5D-5L Quality of life Scores

Incidence of adverse events

Pain

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cutimed® Sorbact®Experimental Treatment1 Intervention

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

Group II: Acticoat®Active Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cutimed® Sorbact®

2022

N/A

~210

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Venous Leg Ulcers (VLUs) often involve the physical binding and removal of bacteria, as seen with products like Cutimed Sorbact. This method is crucial for VLU patients because it directly reduces the bacterial load in the wound, minimizing infection risk and promoting a cleaner environment for healing. By physically removing bacteria without the use of chemical agents, these treatments help facilitate the natural healing process and avoid potential issues like irritation or bacterial resistance.