Clinical trial NCT03370055: LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study
Official title: LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wound Healing Delayed
Keywords: Exposed tendon or bone
LeucoPatch
Plastic Surgery
Granulation tissue
Wound
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Nordsjaellands Hospital
name: Reapplix
First posted: 2017-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: observer blinded, randomised, controlled study
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: Healing rate of Problematic wound area
timeFrame: 8 weeks
Secondary outcomes:
measure: Complete 'problematic wound area´coverage
timeFrame: 8 weeks or until 16 weeks
measure: Complete healing of target wound
timeFrame: 8 or until 16 weeks
measure: Time to complete healing or coverage with granulation tissue
timeFrame: until 16 weeks
measure: Long -term followup
timeFrame: 36 weeks
measure: Local pain
timeFrame: 8 to 16 weeks
measure: Safety
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev - Gentofte Hospital
state: Regionh
Study officials:
affiliation: Nordsjaellands Hospital
name: Lise Tarnow, Professor
role: STUDY_CHAIR
References: