NCT03370055

Brief 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

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 2, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

2.2 years

First QC Date

November 20, 2017

Last Update Submit

November 16, 2020

Conditions

Wound Healing Delayed

Keywords

Exposed tendon or boneLeucoPatchPlastic SurgeryGranulation tissueWound

Outcome Measures

Primary Outcomes (1)

  • Healing rate of Problematic wound area

    Measured as relative reduction of Problematic wound area

    8 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

LeucoPatch®

ACTIVE COMPARATOR

Usual wound care and LeucoPatch® treatment for 8 weeks, with the offer of additional 8 weeks treatment with LeucoPatch®

Device: LeucoPatch®Other: Control,

Control

PLACEBO COMPARATOR

Usual wound care for 8 weeks, with the offer of 8 weeks of LeucoPatch® treatment after the first 8 weeks

Device: LeucoPatch®Other: Control,

Interventions

LeucoPatch®DEVICE

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

ControlLeucoPatch®
Control,OTHER

Usual wound care in a specialized clinic

ControlLeucoPatch®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent obtained before any trial related procedures are performed
  • Aged ≥18 years
  • A documented clinically relevant history of chronic wound with exposed tendon and/or bone. Chronic is defined as a non-healing wound over the past 4 weeks with standard care in a specialized clinic.
  • 'Problematic wound area' between 0.25 and 10.0 cm2 measured by Image J at S1- irrespective of the total wound size
  • The subject must be willing and able to comply with the trial protocol

You may not qualify if:

  • Haemoglobin \< 6.0 mmol/l available at screening (see 10.10)
  • Non-compliance with blood-letting
  • Clinically infected wound or suspected osteomyelitis in the wound area
  • For lower extremity wounds: Critical peripheral artery disease (absence of foot pulse and Ankle-Branchial Pressure Index, ABPI \<0.9 and ankle blood pressure \< 50 mmHg)
  • Malignancy in the wound area
  • Need for dialysis
  • Hemophilia, leukaemia or other significant blood disease
  • History of alcohol or drug abuse within the last year
  • Weight abnormality (BMI \< 20 kg/m2 or \>30 kg/m2)
  • Pregnant or lactating woman
  • Women of childbearing potential who are not using sufficient contraceptives
  • Patient has previously been randomised in this study
  • Participation in another investigational drug trial within the last 10 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev - Gentofte Hospital

Herlev, Regionh, 2730, Denmark

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Lise Tarnow, Professor

    Nordsjaellands Hospital

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A blinded assessor will evaluate wound healing at the first woundhealing and 2 weeks after woundhealing
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: observer blinded, randomised, controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Consultant,

Study Record Dates

First Submitted

November 20, 2017

First Posted

December 12, 2017

Study Start

November 2, 2017

Primary Completion

December 31, 2019

Study Completion

May 1, 2020

Last Updated

November 18, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)