N/A
Completed N=182
Biatain Ag vs Biatain in the Treament of Leg Ulcers
Leg Ulcers
Source: ClinicalTrials.gov NCT00807664 ↗
Enrolled (actual)
182
Serious AEs
6.6%
Results posted
Dec 2017
Primary outcomePrimary: Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline — -41.5; -35.0 Percentage change
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline |
-41.5; -35.0 | — |
| SECONDARY Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline |
-59.7; -46.1 | — |
| SECONDARY Total Number of Adverse Events |
3; 2; 1; 0; 11; 11 | — |
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
Data sourced from ClinicalTrials.gov (NCT00807664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.