Diabetic Foot UlcersNCT01454401
LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
A study testing LeucoPatch treatment in people with Diabetic Foot Ulcers, run by Reapplix at 7 sites in 2 countries.
Trial summary
The LeucoPatch™ study goal is to investigate whether the fully autologous growth factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic foot ulcers. The study seeks to gather data for comparison with previous data from similar wounds (historical controls). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- LeucoPatch treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Oct 2010to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age > 18 years
- Type I or Type II Diabetes
- Age of wounds > 6 weeks
- Wound area <10 cm2
- Wounds: Texas degree ≤ type IIa
- Perfusion status: toe pressure> 30 mmHg, or transcutaneous oxygen measurement (TcPO2)> 30 mmHg on the foot (measured within the last 3 months) or palpable foot pulse (equivalent to> 60 mmHg)
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- Diabetes control: HbA1c <12%
- Adequate off-loading (Walker, therapy sandals etc.)
- The patient can adhere to the treatment protocol and is expected to conclude the study
- Written informed consent
Who cannot join
- Non-Danish or Swedish speaking
- Dementia
- Pregnant or nursing women
- The patient cannot tolerate blood donation
- Hemoglobin : < 6,5 mmol/l or 105 g/l
- Haemophilia, Sickle cell anemia, severe thrombocytopenia, and leukemia or blood dyscrasias.
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- Patient on dialysis
- Clinical signs of infection - including osteomyelitis (probe to bone).
- Necrosis of the wound
- 40% change (+/-) in ulcer area in a 2-week run-in period with optimal therapy.
- Blood vessel reconstruction within the last 4 weeks.
- Participation in other clinical wound healing studies in the last 30 days.
- Failure to comply with study protocol in the 2-week run-in period.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Denmark5 sites
Knowledge Center for woundhealing, Bispebjerg Hospital
Copenhagen, 2400
Steno Diabetes Center
Gentofte Municipality, 2820
Herlev Hospital, Orthopaedic Surgery Infirmary, Wound Clinic
Herlev, 2730
Vascular Center, Wound Clinic Kolding Hospital
Kolding, 6000
University center for woundhealing, Odense Hospital
Odense, 5000
Sweden2 sites
Ängelholm Hospital, Dept. of Medicine, Diabetic Foot Ulcer Clinic
Ängelholm, 262 81
Skane University Hospital, Dept. of Endocrinology, Diabetes Foot Ulcer Clinic
Lund
About this study
Official title: LeucoPatch™ Study. A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
The LeucoPatch™ study goal is to investigate whether the fully autologous growth factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic foot ulcers. The study seeks to gather data for comparison with previous data from similar wounds (historical controls). By subgrouping of the treated wounds (similar to the historical controls used) an assessment of which of the patient and wound-related factors that might indicate a beneficial effect of LeucoPatch™ is sought.
Read the detailed description
Summary: Treatment Study
The goal of the LeucoPatch ™ study is to investigate the effect of LeucoPatch ™ in diabetic foot ulcer. LeucoPatch ™ is a biologically active dressings which are made solely by the patient's own blood (autologous). It is produced in the CE (European Conformity) marked LeucoPatch™ Device and contains no additives. In this treatment study up to 75 typical diabetic patients with foot ulcers are included. These wounds are typically chronic and lead to reduced quality of life and ability to work, and extensive treatment costs. Furthermore, these wounds often lead to amputations.The study is a multicenter study in which up to 10 wound clinics are expected to be involved.
The primary endpoint is time to complete healing, the secondary endpoint is change in wound size.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- LeucoPatch treatment
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeucoPatch treatmentDevice
weekly
| Study group | Role | What they receive |
|---|---|---|
| Weekly LeucoPatch treatment | Other | Weekly treatment of diabetic foot ulcers with LeucoPatch Receives: Device: LeucoPatch treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer Healing Within 20 Weeks
Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population.
Measured: 20 weeks
Secondary outcomes (1)
Ulcer Healing Within 12 Weeks.
Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot UlcersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reapplix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tonny Karlsmark, MD, Principal investigator, Dept. of Dermatology D, Bispebjerg Hospital,Bo Joergensen, MD, Study director, Dept. of Dermatology D, Bispebjerg Hospital,DenmarkAnna Marie Nielsen, MD, Study director, University Center for Wound Healing, Odense University Hospital, DenmarkLise Tarnow, MD,MDSc, Study director, Steno Diabetes Center, Niels Steensensvej 2, 2820 Gentofte, DenmarkMariusz Zakrzewski, MD, Study director, Vascular Center, wound clinic,Kolding Hospital, Skovvangen 2-8,6000 Kolding, DenmarkNiels Ejskjær, MD. PhD, Study director, Medical Endocrinology, Aarhus University Hospital, 8000 AArhuc C, DenmarkMorten Michelsen, MD, Study director, Orthopaedic Surgery, Sårcenter. Herlev Hospital, 2730 Herlev, DenmarkMagnus Löndahl, MD. PhD, Study director, Skane Hospital, Dept Endocrinology, Diabetes Foot Ulcer Clinic, Getingevägen 4, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454401
- Sponsor's protocol ID
- H-4-2010-090
- Status last verified
- Mar 2023
- First submitted
- 14 Oct 2011
- Last updated
- 24 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LeucoPatch™ Study. A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01454401
- Acronym / sponsor ID
- H-4-2010-090
- Conditions
- Diabetic Foot Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ReapplixUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Posted 6 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The LeucoPatch™ study goal is to investigate whether the fully autologous growth factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic foot ulcers. The study seeks to gather data for comparison with previous data from similar wounds (historical controls). By subgrouping of the treated wounds (similar to the historical controls used) an assessment of which of the patient and wound-related factors that might indicate a beneficial effect of LeucoPatch™ is sought.
Detailed description
Summary: Treatment Study
The goal of the LeucoPatch ™ study is to investigate the effect of LeucoPatch ™ in diabetic foot ulcer. LeucoPatch ™ is a biologically active dressings which are made solely by the patient's own blood (autologous). It is produced in the CE (European Conformity) marked LeucoPatch™ Device and contains no additives. In this treatment study up to 75 typical diabetic patients with foot ulcers are included. These wounds are typically chronic and lead to reduced quality of life and ability to work, and extensive treatment costs. Furthermore, these wounds often lead to amputations.The study is a multicenter study in which up to 10 wound clinics are expected to be involved.
The primary endpoint is time to complete healing, the secondary endpoint is change in wound size.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weekly LeucoPatch treatment | Other | Device: LeucoPatch treatmentWeekly treatment of diabetic foot ulcers with LeucoPatch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 years
- Type I or Type II Diabetes
- Age of wounds > 6 weeks
- Wound area <10 cm2
- Wounds: Texas degree ≤ type IIa
Key exclusion criteria (13 listed)
- Non-Danish or Swedish speaking
- Dementia
- Pregnant or nursing women
- The patient cannot tolerate blood donation
- Hemoglobin : < 6,5 mmol/l or 105 g/l
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 treatmentweekly | Device | Weekly LeucoPatch treatment |
Primary outcome
Ulcer Healing Within 20 Weeks
Time frame: 20 weeks
Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population.
1 secondary outcome
Ulcer Healing Within 12 Weeks.
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Tonny Karlsmark, MD principal investigator
Dept. of Dermatology D, Bispebjerg Hospital,
Bo Joergensen, MD study director
Dept. of Dermatology D, Bispebjerg Hospital,Denmark
Anna Marie Nielsen, MD study director
University Center for Wound Healing, Odense University Hospital, Denmark
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LeucoPatch treatment in people with Diabetic Foot Ulcers, run by Reapplix at 7 sites in 2 countries.
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 10 inclusion and 13 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: finished, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark, Sweden. 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. 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?
Yes. Results are posted in the registry (first posted 6 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ulcer Healing Within 20 Weeks (time frame: 20 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 24 Apr 2023.