Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study (LiNWEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370055
Recruitment Status : Withdrawn (Study was closed due to lack of participants)
First Posted : December 12, 2017
Last Update Posted : November 18, 2020
Sponsor:
Collaborators:
Nordsjaellands Hospital
Reapplix
Information provided by (Responsible Party):
Jais Oliver Berg, Nordsjaellands Hospital

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


Condition or disease Intervention/treatment Phase
Wound Healing Delayed Device: LeucoPatch® Other: Control, Not Applicable

Detailed Description:

A certain subpopulation of plastic surgery patients has chronic, non-healing wounds with exposed bone or tendon e.g. located on the scalp or extremities. The chronic non-healing wounds are characterized by no significant wound area reduction within 4 weeks of standard wound treatment. Standard wound treatment includes mechanical or sharp serial debridement and low pressure irrigation for cleansing and wound dressings ensuring moist wound healing. Exposed bone or tendon in a chronic wound can be described as a potentially 'problematic wound area', since the healing by sound granulation tissue from the soft tissue sides of the wound to cover the problematic wound area is often reduced or absent.

The subpopulation is characterized by either referral from other specialties with non-healing wounds of various etiologies and no or limited options of medical, surgical, or reconstructive plastic surgery procedures to treat the wounds; or the wounds are a consequence of previous reconstructive procedures with unsuccessful outcome and no or limited options of further reconstructive surgery. This group of patients often needs wound treatment for a very long period (months-years) to heal, in spite of best practice standards of wound treatment. Treatment with xenogeneic acellular dermal matrixes and autologous full- or split-thickness skin grafts may be an option, but it often requires general anesthesia and a 2-staged approach. The LeucoPatch may be a new solution in wound treatment, which can be used in the outpatient clinic, to promote faster healing in patients with chronic, non-healing wounds with exposed bone or tendon

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: observer blinded, randomised, controlled study
Masking: Single (Outcomes Assessor)
Masking Description: A blinded assessor will evaluate wound healing at the first woundhealing and 2 weeks after woundhealing
Primary Purpose: Treatment
Official Title: LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: LeucoPatch®
Usual wound care and LeucoPatch® treatment for 8 weeks, with the offer of additional 8 weeks treatment with LeucoPatch®
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

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




Primary Outcome Measures :
  1. Healing rate of Problematic wound area [ Time Frame: 8 weeks ]
    Measured as relative reduction of Problematic wound area


Secondary Outcome Measures :
  1. Complete 'problematic wound area´coverage [ Time Frame: 8 weeks or until 16 weeks ]
    Full coverage with granulation tissue of the 'Problematic wound area´ making split -thickness-skin-transplantation for full wound coverage possible

  2. Complete healing of target wound [ Time Frame: 8 or until 16 weeks ]
    Defined as confirmed confirmed wound closure of target wound i.e. skin reepithelization without drainage or dressing requirements (sustained for 2 weeks)

  3. Time to complete healing or coverage with granulation tissue [ Time Frame: until 16 weeks ]
    Defined as time from randomisation to first study visit with confirmed healing or coverage with granulation tissue

  4. Long -term followup [ Time Frame: 36 weeks ]
    Occurence of complete healing 36 weeks after randomisation

  5. Local pain [ Time Frame: 8 to 16 weeks ]
    Local pain measured with Visual Analogue Scale (VAS )

  6. Safety [ Time Frame: 16 weeks ]
    Data on adverse events and serious adverse events including major clinical events will be compared between treatment groups as will changes in haemoglobin



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent obtained before any trial related procedures are performed
  2. Aged ≥18 years
  3. 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.
  4. 'Problematic wound area' between 0.25 and 10.0 cm2 measured by Image J at S1- irrespective of the total wound size
  5. The subject must be willing and able to comply with the trial protocol

Exclusion Criteria:

  1. Haemoglobin < 6.0 mmol/l available at screening (see 10.10)
  2. Non-compliance with blood-letting
  3. Clinically infected wound or suspected osteomyelitis in the wound area
  4. 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)
  5. For lower extremity wounds: History of vascular by-pass graft or other endovascular intervention within 3 months prior to inclusion.
  6. Malignancy in the wound area
  7. Need for dialysis
  8. Hemophilia, leukaemia or other significant blood disease
  9. History of alcohol or drug abuse within the last year
  10. Weight abnormality (BMI < 20 kg/m2 or >30 kg/m2)
  11. Pregnant or lactating woman
  12. Women of childbearing potential who are not using sufficient contraceptives
  13. Patient has previously been randomised in this study
  14. Participation in another investigational drug trial within the last 10 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370055


Locations
Layout table for location information
Denmark
Herlev - Gentofte Hospital
Herlev, Regionh, Denmark, 2730
Sponsors and Collaborators
Jais Oliver Berg
Nordsjaellands Hospital
Reapplix
Investigators
Layout table for investigator information
Study Chair: Lise Tarnow, Professor Nordsjaellands Hospital
Layout table for additonal information
Responsible Party: Jais Oliver Berg, Senior Consultant,, Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT03370055    
Other Study ID Numbers: LiNWEX
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jais Oliver Berg, Nordsjaellands Hospital:
Exposed tendon or bone
LeucoPatch
Plastic Surgery
Granulation tissue
Wound
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries