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

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

Study Overview

• Status: Withdrawn
• Conditions: Wound Healing Delayed
• Intervention / Treatment: Device: LeucoPatch®; Other: Control,

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Regionh
    • Herlev, Regionh, Denmark, 2730
      • Herlev - Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing rate of Problematic wound area	Measured as relative reduction of Problematic wound area	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete 'problematic wound area´coverage	Full coverage with granulation tissue of the 'Problematic wound area´ making split -thickness-skin-transplantation for full wound coverage possible	8 weeks or until 16 weeks
Complete healing of target wound	Defined as confirmed confirmed wound closure of target wound i.e. skin reepithelization without drainage or dressing requirements (sustained for 2 weeks)	8 or until 16 weeks
Time to complete healing or coverage with granulation tissue	Defined as time from randomisation to first study visit with confirmed healing or coverage with granulation tissue	until 16 weeks
Long -term followup	Occurence of complete healing 36 weeks after randomisation	36 weeks
Local pain	Local pain measured with Visual Analogue Scale (VAS )	8 to 16 weeks
Safety	Data on adverse events and serious adverse events including major clinical events will be compared between treatment groups as will changes in haemoglobin	16 weeks

Collaborators and Investigators

• Sponsor: Jais Oliver Berg
• Collaborators: Nordsjaellands Hospital; Reapplix
• Investigators: Study Chair: Lise Tarnow, Professor, Nordsjaellands Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Wound; LeucoPatch; Plastic Surgery; Granulation tissue; Exposed tendon or bone
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: LiNWEX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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