LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study

Wound Healing Delayed Clinical Trial

— LiNWEX  

Official title:

LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03370055
• Other study ID #: LiNWEX
• Status: Withdrawn
• Phase: N/A
• Start date: November 2, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: November 2020
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Healing Delayed
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Denmark	Herlev - Gentofte Hospital	Herlev	Regionh

Sponsors (3)

Lead Sponsor	Collaborator
Jais Oliver Berg	Nordsjaellands Hospital, Reapplix

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing rate of Problematic wound area	Measured as relative reduction of Problematic wound area	8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Long -term followup	Occurence of complete healing 36 weeks after randomisation	36 weeks
Secondary	Local pain	Local pain measured with Visual Analogue Scale (VAS )	8 to 16 weeks
Secondary	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