Biatain Ag vs Biatain in the Treament of Leg Ulcers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00807664
• Date of registration: 11/12/2008
• Prospective Registration: No
• Primary sponsor: Coloplast A/S
• Public title: Biatain Ag vs Biatain in the Treament of Leg Ulcers
• Scientific title: Clinical Assessment of Biatain Ag Dressings Compared to Biatain Dressings in the Treatment of Leg Ulcers
• Date of first enrolment: December 2008
• Target sample size: 182
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00807664
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Leg Ulcers

Intervention(s)

Device: Biatain

Device: Biatain Ag

Primary Outcome(s)

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]

Secondary Outcome(s)

Total Number of Adverse Events [Time Frame: Day 0 to Day 70]

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]

Secondary ID(s)

FR008WS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/12/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00807664