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Biatain Ag vs Biatain in the Treament of Leg Ulcers

This study has been completed.
Sponsor:
Information provided by:
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00807664
First received: December 11, 2008
Last updated: June 2, 2010
Last verified: June 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Leg Ulcers
 Device: Biatain Ag
Device: Biatain
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Assessment of Biatain Ag Dressings Compared to Biatain Dressings in the Treatment of Leg Ulcers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • relative variation in the area of the leg measured by planimetry at week 6 compared to the area at inclusion [ Time Frame: Day 0, 28, 42,70 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • relative reduction of the area of the leg ulcer at 10 weeks [ Time Frame: day 0, D28, D42, D70 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: continuously ] [ Designated as safety issue: Yes ]

Enrollment: 183
Study Start Date: December 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Biatain Ag dressing
 Device: Biatain Ag
Biatain Ag non adhesive ( ColoplastA/S), a polyurethane permeable backing film with an added silver complex, size 15X15. The product is CE marked
Active Comparator: 2
Biatain dressing
 Device: Biatain
A standard polyurethane foam dressing Biatain non adhesive permeable backing film, size15X15 cm. the product is CE marked

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • 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 with a leg ulcer that is not healing properly despite suitable and well-conducted local treatment in the four weeks prior to inclusion
    • Patients with a leg ulcer that has been treated with appropriate compression in the four weeks prior to inclusion
    • Patients who are available for monitoring for at least 10 weeks

Exclusion Criteria:

  • • Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment

    • Patients who have undergone surgery on the saphenous trunk within the two months prior to inclusion
    • Patients whose leg ulcer being considered for the study has been treated with local antibiotics or antiseptics incl. dressings containing antibiotics or antiseptics in the four weeks prior to inclusion
    • Patients who have been taking systemic antibiotics in the two weeks prior to inclusion
    • Patients who have been taking systemic corticoids or cytostatics within the three months prior to inclusion
    • 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ghislaine Martin, Clinical Trial Manager, Coloplast A/S
ClinicalTrials.gov Identifier: NCT00807664     History of Changes
Other Study ID Numbers: FR008WS
Study First Received: December 11, 2008
Last Updated: June 2, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013