Chronic venous leg ulcer MedDRA version: 16.0 Level: LLT Classification code 10066677 Term: Chronic leg ulcer System Organ Class: 100000004858
Conditions
Interventions
Product Code: HP802-247
Pharmaceutical Form: Cutaneous spray
INN or Proposed INN: Keratinocytes
Other descriptive name: GROWTH-ARRESTED KERATINOCYTES
Concentration unit: ml millilitre(s)
Concentration
Sponsors
Smith & Nephew Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Subjects who refuse to provide written informed consent for this study will be excluded from this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess new adverse events, and ongoing adverse events not resolved, in subjects who were exposed to a Investigational Medicinal Product (IMP) in the 802-247-09-032 trial. ;Secondary Objective: Follow-up on the status of the target ulcer as open or closed. Health Econimics To determine if there are differences in Health related Quality of Life (HRQoL) associated with the treatment assignment from the 802 247-09-032 trial.;Primary end point(s): Efficacy The persistence of target wound closure in subjects who achieved a “confirmed” complete wound closure over the treatment period of the preceding study. The persistence of wound closure will be measured by the proportion of subjects whose target wound remains closed at each follow-up visit. Safety - Length of the follow up - Early Termination - Adverse Events;Timepoint(s) of evaluation of this end point: week 1, 2, 3, 4, 5, 6 (at an 8-weeks intervall) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Please Efficacy - The proportion of subjects achieving target wound closure in this follow-up study who had not achieved a “confirmed” complete wound closure in study 802-247-09-032. - The HRQoL measure of SPVU-5D total score will be compared for between-group differences at each follow-up visit by preceding treatment, using analysis of variance (ANOVA).enter information in English and add any other language that is applicable;Timepoint(s) of evaluation of this end point: week 1, 2, 3, 4, 5, 6 (at an 8-weeks intervall) | — |
Countries
Belgium, Czech Republic, Germany, Hungary, Poland
Contacts
Public ContactMedpace Regulatory Submissions
Medpace GmbH
Outcome results
None listed