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LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study

NCT03370055 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-11-18

No results posted yet for this study

Summary

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

Conditions

  • Wound Healing Delayed

Interventions

DEVICE

LeucoPatch®

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

OTHER

Control,

Usual wound care in a specialized clinic

Sponsors & Collaborators

  • Nordsjaellands Hospital

    collaborator OTHER

  • Reapplix

    collaborator OTHER

  • Jais Oliver Berg

    lead OTHER

Principal Investigators

  • Lise Tarnow, Professor · Nordsjaellands Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-02
Primary Completion
2019-12-31
Completion
2020-05-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03370055 on ClinicalTrials.gov