This is a randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. The study will be conducted at a single center with a total of 70 patients. Patients will be randomized to either the octenisept® group or to the placebo group.
Randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. The study will be conducted at a single center with a total of 70 patients. Patients will be randomized to either the octenisept® group or to the placebo group. Primary Objectives: Antimicrobial efficacy of octenisept® compared to placebo. Secondary Objectives: Subjective tolerance of octenisept®, evaluation of wound parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
9
Cutaneous solution
Cutaneous use
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Antimicrobial efficacy of octenisept® compared to placebo
Decrease of bacterial load after 2 weeks of treatment
Time frame: 2 weeks after baseline
Subjective tolerance of octenisept®
Clinical signs of tolerance of octenisept®
Time frame: 2 weeks after baseline
Evaluation of wound parameters
Evaluation of wound healing time and wound size (Planimetry)
Time frame: 2 weeks after baseline
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