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OpenTrials
Completed

NCT Number: NCT00807664

Biatain Ag vs Biatain in the Treament of Leg Ulcers

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

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Key information

Conditions

Leg Ulcers Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biatain

Device

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

Primary outcomes

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

    Time frame: Day 0 to Day 42

    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.

Secondary outcomes

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

    Time frame: Day 0 to Day 70

    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.

  2. Total Number of Adverse Events

    Time frame: Day 0 to Day 70

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Clinical Assessment of Biatain Ag Dressings Compared to Biatain Dressings in the Treatment of Leg Ulcers

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 12, 2008
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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