NCT05923749

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
4 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

June 29, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2025

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

June 14, 2023

Last Update Submit

May 21, 2025

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

  • Wound healing

    Relative wound area change measured by calculation of area based on photo of wound

    After 4 weeks

Secondary Outcomes (3)

  • Wound area reduction

    After 4 weeks

  • Wound healing

    After 12 weeks

  • Quality of Life (based on Wound-Quality of Life-17 questionnaire)

    After 4 and 12 weeks

Study Arms (2)

Biatain Ag

EXPERIMENTAL
Device: Biatain Ag

Cutimed Siltec Sorbact

ACTIVE COMPARATOR
Device: Cutimed Siltec Sorbact

Interventions

Biatain AgDEVICE

Biatain with silver

Biatain Ag
Cutimed Siltec SorbactDEVICE

comparator device

Cutimed Siltec Sorbact

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • Is pregnant or breastfeeding
  • Has wounds with exposed tendons, bones, fistulas. Or wounds with cavity, undermined or tunnelling
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Royal Research, Corp.

Hollywood, Florida, 33021, United States

Location

Three Rivers Wound and Research Center

North Port, Florida, 34289, United States

Location

Detroit foot and ankle Specialists

Clinton Township, Michigan, 48038, United States

Location

SerenaGroup Research Center Omaha

Omaha, Nebraska, 68114, United States

Location

Serena Group

Monroeville, Pennsylvania, 15146, United States

Location

Dermato-Venerologisk Afd

Copenhagen, 2400, Denmark

Location

Wundmanagement Gefäßzentrum Aachen Wundmanagement

Aachen, 52066, Germany

Location

Katholisches Klinikum Bochum

Bochum, 44791, Germany

Location

Krankenhaus Buchholz und Winsen gemeinnüzige GmbH

Buchholz, 21244, Germany

Location

ProDerma

Dülmen, 48249, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitätsklinikum Giessen und Marburg GmbH

Giessen, 35385, Germany

Location

Pioneer Wound Healing and Lymphedema centres

Eastbourne, BN23 8AS, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 28, 2023

Study Start

June 29, 2023

Primary Completion

January 29, 2025

Study Completion

January 29, 2025

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(5)DK(1)GB(1)DE(6)