NCT03370055|WithdrawnDMC
Study Stopped
Study was closed due to lack of participants
LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study
LiNWEX
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Sponsor study identifier
interventional
0
1 country
1
Study Start
November 2, 2017
Actual (reported)Primary Completion
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The trial compare the healing rate of chronic wounds with exposed tendon or bone ('problematic wound area') with LeucoPatch® treatment for 8 up to 16 weeks in addition to usual care versus usual care. The healing rate will be measured as relative reduction of 'problematic wound area' at 8 weeks
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2, 2017
Actual (reported)November 20, 2017
Actual (reported)December 12, 2017
Actual (reported)December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Healing rate of Problematic wound area
Measured as relative reduction of Problematic wound area
8 weeks
Complete 'problematic wound area´coverage
8 weeks or until 16 weeks
Complete healing of target wound
8 or until 16 weeks
Time to complete healing or coverage with granulation tissue
until 16 weeks
Long -term followup
36 weeks
Local pain
8 to 16 weeks
Usual wound care and LeucoPatch® treatment for 8 weeks, with the offer of additional 8 weeks treatment with LeucoPatch®
Usual wound care for 8 weeks, with the offer of 8 weeks of LeucoPatch® treatment after the first 8 weeks
LeucoPatch® is an elastic membrane produced by the patients own venous blood by centrifugation, and one or two is placed on the wound once a week The LeucoPatch® consist of the fibrin Leucocytes and growth factors from the patients own blood
Usual wound care in a specialized clinic
Herlev - Gentofte Hospital
Herlev, Regionh, 2730, Denmark
Lise Tarnow, Professor
Nordsjaellands Hospital
0 participants (actual enrollment reported by the registry).
First Submitted
November 20, 2017
First Posted
December 12, 2017
Study Start
An Exploratory Research on the Efficacy and Safety of Antibacterial Absorbable Dressing in Chronic Non-healing Wounds
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
November 2, 2017
Primary Completion
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 18, 2020
Record last verified: 2020-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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