12 months study to observe safety of patients treated with HP802-247 in study 802-247-09-032(EU)

• Conditions: Chronic venous leg ulcer; MedDRA version: 16.0Level: LLTClassification code 10066677Term: Chronic leg ulcerSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-000949-39-CZ
• Lead Sponsor: Smith & Nephew Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-26
• Last Update Posted: 4 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

- The informed consent document must be read, signed, and dated by the subject or the subject’s legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject’s chart.
- Subject was randomized in 802-247-09-032 and received at least one application of test article.
- Subject has ended their participation in 802-247-09-032 by virtue of completing the study, or by dropping out prior to completion.
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 264
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 176

Exclusion Criteria

Subjects who refuse to provide written informed consent for this study will be excluded from this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified