Prospective randomized controlled double-blind multicentric phase III study to evaluate antiseptic efficacy and local tolerability of Stellisept mucosa in patients with chronic wounds

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000061-11-DE

Enrollment

Registered

2006-03-03

Start date

2006-04-03

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ulcus cruris

Interventions

Product Name: Stellisept mucosa Product Code: VP 514 Pharmaceutical Form: Cutaneous solution INN or Proposed INN: [N.N´-(Decan-(1,10 decandiyldi-1[4H]-pyridinyl-4-ylidene)bis-(1-octanamine)dihydrochlo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: male and female 18-80 years use of contraceptives if applicable no pregnancy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: age below 18 or over 80 pregnant women /nursing mother severe accompanying disease known allergy to the drug or one of its ingredients missing informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: demonstrate antiseptic efficacy of product;Secondary Objective: demonstrate local tolerability of product;Primary end point(s): antiseptic efficacy (reduction of baterial load	—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026