Biatain Ag vs Biatain in the Treament of Leg Ulcers

NCT00807664 | Completed Results

• 1 other identifier: FR008WS
• Study Type: interventional
• Target: 182
• Locations: 0 countries
• Sites: N/A

Brief Summary

the objective of this investigation is to demonstrate the effect of the foam dressing Biatain Ag, compared to Biatain foam dressing( a product which is similar but does not contain a silver complex, in the healing of leg ulcers that had failed to heal despite appropriate therapy

Conditions

Leg Ulcers

Outcome Measures

Primary Outcomes (1)

• Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline

  The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation: Area= Lenght \*Width \* pi \[3.142\] / 4 All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used.

  Day 0 to Day 42

Secondary Outcomes (2)

• Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline

  Day 0 to Day 70

• Total Number of Adverse Events

  Day 0 to Day 70

Study Arms (2)

1

EXPERIMENTAL

Biatain Ag dressing

Device: Biatain Ag

2

ACTIVE COMPARATOR

Biatain dressing

Device: Biatain

Interventions

Biatain Ag DEVICE

Biatain Ag non adhesive ( ColoplastA/S), a polyurethane permeable backing film with an added silver complex, size 15X15. The product is CE marked

1

Biatain DEVICE

A standard polyurethane foam dressing Biatain non adhesive permeable backing film, size15X15 cm. the product is CE marked

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 who have given written informed consent
• Patients with a venous or predominantly venous leg ulcer (ankle-brachial index \> 0.8) that is between 2 cm and 13 cm in all directions
• Patients with a moderately or severely exudating leg ulcer in the phase of debridement or formation of granulation tissue
• Patients who are available for monitoring for at least 10 weeks

You may not qualify if:

• Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment
• Patients with unbalanced diabetes at the discretion of the investigator
• Patients with a known allergy to one of the components in Biatain Argent® or Biatain
• Patients who are already taking part in another clinical study
• Patients who are pregnant or breastfeeding

Sponsors & Collaborators

• Coloplast A/S: lead

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr Birte Petersen Jacobsen
• Organization: Coloplast

DKBIR@coloplast.com

004549110000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 12, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 16, 2018
• Results First Posted: December 11, 2017

Record last verified: 2018-01