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Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcers

Primary Purpose

Venous Leg Ulcer

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biatain Fiber Ag applied to participants
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer focused on measuring wound healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Has signed informed consent Is 18 years or above Is capable of following study procedure (assessed by the investigator). Has a venous leg ulcer that has failed to progress along the expected wound healing trajectory within 4 weeks The shape of the wound should be possible to fit under a 10x10 cm dressing The shape and location of the wound should be suitable for photo capture (assessed by the investigator). Has at least three of five pre-defined clinical signs of infection; pain between two dressing changes, peri-ulcer skin erythema/inflammation, oedema, malodour, or heavy exudate (assessed by the investigator). Has a wound that has medium to high level of exudate (assessed by the investigator). Has an ankle to brachial pressure index (ABPI) of 0.8 -1.3 Agrees to wear compression therapy daily in combination with the test dressing Is suitable to use the test product for wound treatment (assessed by the investigator). Exclusion Criteria: Is pregnant/breastfeeding Wound is older than 12 months Wound with exposed tendons or bones or has fistulas Wound which is undermined or tunneling Is currently receiving or has within the past 60 days received radio- and/or chemotherapy (low doses radio- and/or chemotherapy is allowed for other indications than cancer if assessed by investigator not to influence study wound area) Known history of skin sensitivity to any components of the treatment dressings Intake of antibiotics within one week before the start of the enrolment Participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).

Sites / Locations

  • Serena Group

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

main arm

Arm Description

Non comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a four weeks period with planned dressing changes once pr. week.

Outcomes

Primary Outcome Measures

Mean relative wound area reduction as indication of total wound healing
Wound area will be measured by obtaining photos of the wounds and measure these afterwards. A planimetric software will be used where the wound is photographed with a ruler of known dimensions placed at the skin near the wound edge and the image is transferred to a computer and opened in the planimetric software. The ruler is used for calibration of linear dimensions at the image. Once the wound border is manually traced with a computer mouse the area of wound is calculated and displayed.

Secondary Outcome Measures

Full Information

First Posted
May 1, 2023
Last Updated
June 23, 2023
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05873257
Brief Title
Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcers
Official Title
Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Suspended
Why Stopped
unknown if investigation will be conducted
Study Start Date
July 31, 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
March 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to test a new gelling fiber wound dressing with silver on patients with a venous leg ulcer Participants will be asked to wear the test dressing in a four weeks period (+/- 2 days) consisting of 6 study visits, and will have the dressing changed once pr. week at the research facility. The wound will be cleaned, assessed and photos will be uploaded to a digital software system.
Detailed Description
: The clinical investigation is a non-comparative, one-armed, open-labelled, multi-centre study The test product, Biatain Fiber Ag is a non-CE-marked gelling fiber wound dressing, containing silver. The product is intended for moist wound healing and exudate management of moderate to high exuding wounds. The overall purpose of this investigation is to obtain clinical data supporting effectiveness of Biatain Fiber Ag to obtain the CE-mark in EU. The total study duration for the subject will be approximately four weeks, consisting of a four-week test period and 6 study visits (V0/V1, V2, V3, V4 and V5). V5 will also terminate the 4-week study period. The primary endpoint is Mean area wound reduction. The endpoint is used to evaluate clinical performance in terms of relative wound area reduction as an indication of total wound healing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
Keywords
wound healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
non-comparative, one-armed, open-labelled, multi-centre study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
main arm
Arm Type
Other
Arm Description
Non comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a four weeks period with planned dressing changes once pr. week.
Intervention Type
Device
Intervention Name(s)
Biatain Fiber Ag applied to participants
Intervention Description
Intervention involving a wound gelling fiber dressing with silver
Primary Outcome Measure Information:
Title
Mean relative wound area reduction as indication of total wound healing
Description
Wound area will be measured by obtaining photos of the wounds and measure these afterwards. A planimetric software will be used where the wound is photographed with a ruler of known dimensions placed at the skin near the wound edge and the image is transferred to a computer and opened in the planimetric software. The ruler is used for calibration of linear dimensions at the image. Once the wound border is manually traced with a computer mouse the area of wound is calculated and displayed.
Time Frame
period of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has signed informed consent Is 18 years or above Is capable of following study procedure (assessed by the investigator). Has a venous leg ulcer that has failed to progress along the expected wound healing trajectory within 4 weeks The shape of the wound should be possible to fit under a 10x10 cm dressing The shape and location of the wound should be suitable for photo capture (assessed by the investigator). Has at least three of five pre-defined clinical signs of infection; pain between two dressing changes, peri-ulcer skin erythema/inflammation, oedema, malodour, or heavy exudate (assessed by the investigator). Has a wound that has medium to high level of exudate (assessed by the investigator). Has an ankle to brachial pressure index (ABPI) of 0.8 -1.3 Agrees to wear compression therapy daily in combination with the test dressing Is suitable to use the test product for wound treatment (assessed by the investigator). Exclusion Criteria: Is pregnant/breastfeeding Wound is older than 12 months Wound with exposed tendons or bones or has fistulas Wound which is undermined or tunneling Is currently receiving or has within the past 60 days received radio- and/or chemotherapy (low doses radio- and/or chemotherapy is allowed for other indications than cancer if assessed by investigator not to influence study wound area) Known history of skin sensitivity to any components of the treatment dressings Intake of antibiotics within one week before the start of the enrolment Participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).
Facility Information:
Facility Name
Serena Group
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcers

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