A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-29

Study Completion Date

2025-01-29

Brief Summary

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Approximately 178 patients with a venous leg ulcer will be included in the investigation evaluating wound healing. All subjects are randomized to one of two treatment arms with an intervention period of 4 weeks followed by a 8 week standard of care period.

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Detailed Description

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Conditions

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Wound Heal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biatain Ag

Group Type EXPERIMENTAL

Biatain Ag

Intervention Type DEVICE

Biatain with silver

Cutimed Siltec Sorbact

Group Type ACTIVE_COMPARATOR

Cutimed Siltec Sorbact

Intervention Type DEVICE

comparator device

Interventions

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Biatain Ag

Biatain with silver

Intervention Type DEVICE

Cutimed Siltec Sorbact

comparator device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Has signed informed consent
* Is above 18 years of age or above and has full legal capacity
* Has venous leg ulcer (C6 of the CEAP classification) with a duration longer than 4 weeks but no longer than 5 years
* Has acceptance of compression bandages
* Has a wound at risk of infection based on WAR (wounds at risk of infection) score with score of ≥3 points OR has at least three of the following clinical signs of bacterial contamination based on the Therapeutic index for local infections (TILI) score:

* Erythema to surrounding skin
* Heat
* Oedema, induration or swelling
* Spontaneous pain or pressure pain
* Stalled wound healing
* Increase and/or change of color or smell of exudate
* Has wound area of min 1x1 cm and max 10x10 cm
* Has wound with depth of max 2 cm
* Has wound with medium to high level of exudate (but should not require more than 1 dressing change/day)
* Has ankle-brachial pressure (ABI) ≥0.8 AND, for patients with diabetes mellitus, additional biphasic Doppler signal up to the ankle
* Ability (assessed by the investigator) and willingness to adhere to a 1-month intervention period
* For patients with diabetes, has HbA1c ≤ 10%/≤ 86 mmol/mol, measured within the last 3 months prior to inclusion
* Should be able to follow the study protocol with the prescribed cleansing product (NaCl) and dressing

Exclusion Criteria

* Is pregnant or breastfeeding
* Has wounds with exposed tendons, bones, fistulas. Or wounds with cavity, undermined or tunnelling
* Has infection requiring antibiotics (also for other reasons than wound infection) OR has received antibiotics within the last 1 week before inclusion
* Has been receiving the following medical treatment within the last 4 weeks: immunosup-pression, immunomodulating, cytostatic medi-cation or corticoids (topical except for in the wound, inhalation, and stable systemic treat-ment up to 5 mg per day (stable defined as minimum 4 weeks) is allowed
* Has a systemic hematological disease
* Has renal insufficiency requiring dialysis
* Has advanced heart failure NYHA III/IV
* Has a psychiatric illness that inhibits compliance with the study protocol
* Has severe congenital immunodeficiency such agammaglobulinemia, severe combined immunodeficiency (SCID)
* Has allergy towards silver or other dressing ingredients (including compression therapy)
* Has wound with \> 50% necrotic tissue
* Treatment of wound with an anti-microbial wound dressing within the last 2 weeks

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No