Wound Healing DelayedLiNWEXNCT03370055
LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study
A study testing LeucoPatch® in people with Wound Healing Delayed, run by Jais Oliver Berg at 1 site in Denmark.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing Delayed
- What is being tested?
- LeucoPatch®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Nov 2017to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- For lower extremity wounds: History of vascular by-pass graft or other endovascular intervention within 3 months prior to inclusion.
- Malignancy in the wound area
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Wound Healing Delayed
- Being tested
- LeucoPatch®, Control,
- Keywords
- Exposed tendon or bone, LeucoPatch, Plastic Surgery, Granulation tissue, Wound
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Control,Other
Usual wound care in a specialized clinic
| Study group | Role | What they receive |
|---|---|---|
| LeucoPatch® | Active comparator | Usual wound care and LeucoPatch® treatment for 8 weeks, with the offer of additional 8 weeks treatment with LeucoPatch® Receives: 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 Receives: Device: LeucoPatch®; Other: Control, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rate of Problematic wound area
Measured as relative reduction of Problematic wound area
Measured: 8 weeks
Secondary outcomes (6)
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
Measured: 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)
Measured: 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
Measured: until 16 weeks
Long -term followup
Occurence of complete healing 36 weeks after randomisation
Measured: 36 weeks
Local pain
Local pain measured with Visual Analogue Scale (VAS )
Measured: 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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start2 Nov 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion1 May 2020 (estimated)
Why it stopped: Study was closed due to lack of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Healing DelayedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- observer blinded, randomised, controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jais Oliver Berg
- Sponsor type
- University, hospital or other
- Collaborators
- Nordsjaellands Hospital, Reapplix
- Responsible party
- Sponsor-investigator, Jais Oliver Berg, Nordsjaellands Hospital
- Investigators
- Lise Tarnow, Professor, Study chair, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370055
- Sponsor's protocol ID
- LiNWEX
- Acronym
- LiNWEX
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2017
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study
- ClinicalTrials.gov ID
- NCT03370055
- Acronym / sponsor ID
- LiNWEX / LiNWEX
- Conditions
- Wound Healing Delayed
- Keywords
- Exposed tendon or bone, LeucoPatch, Plastic Surgery, Granulation tissue, Wound
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was closed due to lack of participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jais Oliver BergUniversity, hospital or other
- Collaborators
- Nordsjaellands Hospital, Reapplix
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- observer blinded, randomised, controlled study
| Arm | Type | Receives |
|---|---|---|
| LeucoPatch® | Active comparator | Device: LeucoPatch®, Other: Control,Usual wound care and LeucoPatch® treatment for 8 weeks, with the offer of additional 8 weeks treatment with LeucoPatch® |
| Control | Placebo comparator | Device: LeucoPatch®, Other: Control,Usual wound care for 8 weeks, with the offer of 8 weeks of LeucoPatch® treatment after the first 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
- For lower extremity wounds: History of vascular by-pass graft or other endovascular intervention within 3 months prior to inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Control, LeucoPatch® |
| Control,Usual wound care in a specialized clinic | Other | Control, LeucoPatch® |
Primary outcome
Healing rate of Problematic wound area
Time frame: 8 weeks
Measured as relative reduction of Problematic wound area
6 secondary outcomes
Complete 'problematic wound area´coverage
Time frame: 8 weeks or until 16 weeks
Complete healing of target wound
Time frame: 8 or until 16 weeks
Time to complete healing or coverage with granulation tissue
Time frame: until 16 weeks
Long -term followup
Time frame: 36 weeks
Local pain
Time frame: 8 to 16 weeks
Safety
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Tarnow, Professor study chair
Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LeucoPatch® in people with Wound Healing Delayed, run by Jais Oliver Berg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate of Problematic wound area (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.