NCT03444597

Brief Summary

Post-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2020

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

February 8, 2018

Last Update Submit

February 18, 2020

Conditions

Venous or Mixed Leg Ulcers

Outcome Measures

Primary Outcomes (1)

  • Progression of healing after application of Suprasorb® C collagen wound dressing is used as parameter for performance evaluation

    Progression of healing after application of Suprasorb® C collagen

    Progression of healing is assessed at 8 weeks

Secondary Outcomes (1)

  • Frequency and severity of adverse events

    Frequency and severity is assessed up to 8 weeks

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patient population is patient with venous or mixed leg ulcers

You may qualify if:

  • Patient over 18 years of age and under 85 years of age
  • Patient suffering from confirmed venous or mixed vascular leg ulcers
  • Stagnating wound conditions, i.e. exudation phase \> 2 months, not responding to traditional dressing and standard treatment (standard treatment is a clear definition and for venous ulcers compression should be included)
  • Target ulcers between 2 cm and 10 cm in the largest diameter
  • Written confirmation from the study nurse that the patient was informed, orally agreed to participate and to comply with study treatment and planned visits

You may not qualify if:

  • Use of Suprasorb® C collagen wound dressing is contraindicated according to the current IFU:
  • Clinically infected areas
  • Presence of known allergies to one or several of its components.
  • In addition following patients shall not be included into this study:
  • Patient not covered by health insurance/social security
  • Patient suffering serious life threatening disease
  • Pregnant or breastfeeding women
  • Minor patient, protected adult, person without liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RCTs

Lyon, 69002, France

Location

Study Officials

  • Daria TROFIMENKO

    Lohmann and Rauscher

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 23, 2018

Study Start

January 24, 2018

Primary Completion

January 23, 2020

Study Completion

January 23, 2020

Last Updated

February 19, 2020

Record last verified: 2020-02

Locations

FR(1)