Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcers
NCT05873257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-06-03
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.
Conditions
- Venous Leg Ulcer
Interventions
- DEVICE
-
Biatain Fiber Ag applied to participants
Intervention involving a wound gelling fiber dressing with silver
Sponsors & Collaborators
-
Coloplast A/S
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-31
- Primary Completion
- 2024-05-17
- Completion
- 2024-05-17
Countries
- United Kingdom
Study Locations
More Related Trials
-
Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers
NCT00998673 ·Status: TERMINATED ·Phase: PHASE2
-
Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers
NCT00627094 ·Status: COMPLETED ·Phase: NA
-
DURAFIBER Ag Post-Market Clinical Follow-Up
NCT03277131 ·Status: COMPLETED ·Phase: NA
-
Microlyte Dressing in the Management of Wounds
NCT03204851 ·Status: UNKNOWN ·Phase: NA
-
Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers
NCT01396304 ·Status: TERMINATED ·Phase: PHASE4
-
Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers
NCT01105884 ·Status: WITHDRAWN ·Phase: NA
-
Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers
NCT01036438 ·Status: COMPLETED ·Phase: PHASE4
-
Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers
NCT00349700 ·Status: COMPLETED ·Phase: NA
-
Study of VF001-DP in Patients With Chronic Venous Leg Ulcers
NCT02973893 ·Status: UNKNOWN ·Phase: PHASE2
-
Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin
NCT02921750 ·Status: COMPLETED ·Phase: NA
-
Randomized Controlled 8-week Crossover Evaluation of Compression Bandage Systems for Venous Leg Ulcers
NCT00301496 ·Status: COMPLETED ·Phase: NA
-
A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers
NCT00235209 ·Status: COMPLETED ·Phase: PHASE4
-
Wool-derived Keratin Dressings for Venous Leg Ulcers
NCT02896725 ·Status: COMPLETED ·Phase: NA
-
AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers
NCT01084577 ·Status: COMPLETED ·Phase: PHASE4
-
AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
NCT05892341 ·Status: COMPLETED ·Phase: NA
-
Randomized Clinical Trial (RCT) to Compare the Efficacy of Coban 2 Versus SSB in the Treatment of Venous Leg Ulcers
NCT00558662 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
NCT00399308 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
NCT01656889 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of Care
NCT05786612 ·Status: COMPLETED ·Phase: NA
-
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
NCT01737762 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
NCT05588583 ·Status: RECRUITING ·Phase: NA
-
EASH Dressing on Chronic Venous Leg Ulcers
NCT01497210 ·Status: COMPLETED ·Phase: PHASE2
-
Assessment of the Wound Healing Efficacy and Tolerance of a Medical Device on Wounds in Healthy Subjects.
NCT04687839 ·Status: COMPLETED ·Phase: NA
-
A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
NCT05608317 ·Status: RECRUITING ·Phase: NA
-
Effectiveness of XCell on Autolytic Debridement of Venous Ulcers
NCT00446823 ·Status: COMPLETED ·Phase: NA