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| Biatain Ag vs Biatain in the Treament of Leg Ulcers |
| Link to the ClinicalTrials.gov record | Information obtained from ClinicalTrials.gov on February 23, 2012 |
| Title of trial/grant title | Biatain Ag vs Biatain in the Treament of Leg Ulcers |
| Current status of trial | Completed |
| Sponsors and collaborators | Coloplast A/S |
| Information provided by | Coloplast A/S |
| ClinicalTrials.gov identifier | NCT00807664 |
| 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(s) | Leg Ulcers |
| Intervention(s) | Device: Biatain Ag Device: Biatain |
| Phase | Phase IV |
| Study type and 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 |
| Primary outcome | relative variation in the area of the leg measured by planimetry at week 6 compared to the area at inclusion Day 0, 28, 42,70 No |
| Secondary outcome | relative reduction of the area of the leg ulcer at 10 weeks day 0, D28, D42, D70 No Adverse events continuously Yes |
| Study start | December 2008 |
| Minimum age | 18 Years |
| Maximum age | N/A |
| Gender | Both |
| Eligibility 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 |
| Study ID numbers | FR008WS |
| Last updated | June 2, 2010 |
| Record first received | December 11, 2008 |
| ClinicalTrials.gov identifier | NCT00807664 |
| Download date | Information obtained from ClinicalTrials.gov on February 23, 2012 |
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