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The LeucoPatchâ„¢ study goal is to investigate whether the fully autologous growth factor-containing dressing LeucoPatchâ„¢ 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 LeucoPatchâ„¢ is sought.
Summary: Treatment Study
The goal of the LeucoPatch â„¢ study is to investigate the effect of LeucoPatch â„¢ in diabetic foot ulcer. LeucoPatch â„¢ 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 LeucoPatchâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weekly LeucoPatch treatment | Other | Weekly treatment of diabetic foot ulcers with LeucoPatch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LeucoPatch treatment | Device | weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer Healing Within 20 Weeks | Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population. | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tonny Karlsmark, MD | Dept. of Dermatology D, Bispebjerg Hospital, | Principal Investigator |
| Bo Joergensen, MD | Dept. of Dermatology D, Bispebjerg Hospital,Denmark | Study Director |
| Anna Marie Nielsen, MD | University Center for Wound Healing, Odense University Hospital, Denmark | Study Director |
| Lise Tarnow, MD,MDSc | Steno Diabetes Center, Niels Steensensvej 2, 2820 Gentofte, Denmark | Study Director |
| Mariusz Zakrzewski, MD | Vascular Center, wound clinic,Kolding Hospital, Skovvangen 2-8,6000 Kolding, Denmark | Study Director |
| Niels Ejskjær, MD. PhD | Medical Endocrinology, Aarhus University Hospital, 8000 AArhuc C, Denmark | Study Director |
| Morten Michelsen, MD | Orthopaedic Surgery, SÃ¥rcenter. Herlev Hospital, 2730 Herlev, Denmark | Study Director |
| Magnus Löndahl, MD. PhD | Skane Hospital, Dept Endocrinology, Diabetes Foot Ulcer Clinic, Getingevägen 4, Lund, Sweden | Study Director |
| Anders Nilsson, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knowledge Center for woundhealing, Bispebjerg Hospital | Copenhagen | 2400 | Denmark | |||
| Steno Diabetes Center |
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16 patients were excluded during run-in period: >40% ulcer area reduction n=5 HbA1c > 12% n=3 haemoglobin < 9,5% g/dl, n=1 ulcer area > 10 cm2, n=1 amputation n=1 withdrawn consent, n=2 Osteomyelitis n=1 wrongly included n=2
Recruitment period: 18-01-2011 (FPI) to 14-01-2013 (LPO)
Non -ischemic Wagner grade 1 or 2 diabetic foot ulcer (DFU) with a duration of more than 6 weeks and a maximal area of 10 cm2
Patients with > 40% ulcer area change during a two-week run-in period were excluded.
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| ID | Title | Description |
|---|---|---|
| FG000 | LeucoPatch Treatment of Diabetic Foot Ulcers | Weekly LeucoPatch treatment of diabetic foot ulcers |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LeucoPatch Treatment of Diabetic Foot Ulcers | Weekly treatment LeucoPatch device: weekly treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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 | Complete epithelialisation was achieved in 15 patients (34%) in ITT population and 38% in the PP population | Posted | Number | participants | 12 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients Consenting to be Enrolled in the Study. | 60 patients were included for a 2 week run-in period. If ulcer area decreased more than 40% during that time the ulcer were deemed "healing" and NOT included for treatment. 16 patients were excluded during the run-in period - 44 were treated. For safety analysis all patients were included |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SAE not related to Leucopatch treatment | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AE | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MD, PhD Senior Consultant Magnus Löndahl | Reapplix Blokken 45 3460 Birkerød Denmark | magnus.londahl@med.lu.se |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| Ängelholm Hospital, Diabetes Foot Ulcer Clinic, 262 81 Ängelholm Sweden |
| Study Director |
| Gentofte Municipality |
| 2820 |
| Denmark |
| Herlev Hospital, Orthopaedic Surgery Infirmary, Wound Clinic | Herlev | 2730 | Denmark |
| Vascular Center, Wound Clinic Kolding Hospital | Kolding | 6000 | Denmark |
| University center for woundhealing, Odense Hospital | Odense | 5000 | Denmark |
| Ängelholm Hospital, Dept. of Medicine, Diabetic Foot Ulcer Clinic | Ängelholm | 262 81 | Sweden |
| Skane University Hospital, Dept. of Endocrinology, Diabetes Foot Ulcer Clinic | Lund | Sweden |
| non-adherence |
|
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Diabetes | Number | participants |
|
| Body Mass Index (kg/m2) | Median | Inter-Quartile Range | kg/m^2 |
|
| Presence of neuropathy | Number | participants |
|
| Ulcer duration (weeks) | Median | Inter-Quartile Range | weeks |
|
| Ulcer area | Median | Inter-Quartile Range | cm^2 |
|
| Wagner classification | The Wagner classification is based mainly on wound depth and consists of 6 wound grades. These include: grade 0 (intact skin), grade 1 (superficial ulcer), grade 2 (deep ulcer to tendon, bone, or joint), grade 3 (deep ulcer with abscess or osteomyelitis), grade 4 (forefoot gangrene), and grade 5 (whole foot gangrene). | Number | participants |
|
| Biochemistry Haemoglobin | Median | Inter-Quartile Range | g/l |
|
| Biochemistry | Median | Inter-Quartile Range | 10^9 cells/l |
|
| HbA1c | Median | Inter-Quartile Range | % |
|
| HbA1c | Median | Inter-Quartile Range | mmol/mol |
|
|
| Primary | Ulcer Healing Within 20 Weeks | Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population. | Number of the patients achieved complete epithelialisation at 20 weeks in the ITT population and in the PP population | Posted | Number | participants | 20 weeks |
|
|
|
| 8 |
| 60 |
| 21 |
| 60 |
| SAE not related to Leucopatch treatment | Cardiac disorders | Systematic Assessment |
|
| SAE not related to Leucopatch treatment | Vascular disorders | Amputation | Systematic Assessment |
|
| SAE not related to Leucopatch treatment | Respiratory, thoracic and mediastinal disorders | Pneumonia | Systematic Assessment |
|
| SAE not related to Leucopatch treatment | Blood and lymphatic system disorders | Low haemoglobin | Systematic Assessment |
|
| SAE not related to Leucopatch treatment | Cardiac disorders | death | Systematic Assessment |
|
| SAE not related to Leucopatch treatment | Surgical and medical procedures | Colonscopy | Systematic Assessment |
|
| AE | Skin and subcutaneous tissue disorders | necrotic tissue | Systematic Assessment |
|
| AE | Skin and subcutaneous tissue disorders | New ulcer | Systematic Assessment |
|
| AE | Investigations | Leucopatch Treatment | Systematic Assessment | Two weeks between treatments |
|
| AE | Surgical and medical procedures | Femur fractur | Systematic Assessment |
|
| AE | Blood and lymphatic system disorders | Anaemia | Systematic Assessment |
|
| AE | Gastrointestinal disorders | Systematic Assessment |
|
| AE | Renal and urinary disorders | Systematic Assessment |
|
| AE | Blood and lymphatic system disorders | Bleeding | Systematic Assessment |
|
| AE | Blood and lymphatic system disorders | Dizziness | Systematic Assessment |
|
| AE | Skin and subcutaneous tissue disorders | Systematic Assessment | Stinging sensation in wound area |
|
| AE | Metabolism and nutrition disorders | Systematic Assessment | Hypertension medication stop |
|
| AE | Renal and urinary disorders | Low kidney function | Systematic Assessment |
|
| AE | General disorders | Systematic Assessment | Not taken medication |
|
| AE | Injury, poisoning and procedural complications | Maggot in wound | Systematic Assessment |
|
| AE | Skin and subcutaneous tissue disorders | Erysipelas | Systematic Assessment |
|
| AE | General disorders | Systematic Assessment | Problem blood taking |
|
| AE | General disorders | Systematic Assessment | Device related problems |
|
| AE | Skin and subcutaneous tissue disorders | Systematic Assessment | Increase in exudate |
|
| AE | Skin and subcutaneous tissue disorders | Osteomylitis | Systematic Assessment |
|
| AE | Skin and subcutaneous tissue disorders | Systematic Assessment | Blister after footbath |
|
| AE | General disorders | Penicillin treatment | Systematic Assessment |
|
| AE | General disorders | Device crash | Systematic Assessment |
|
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| Title | Measurements |
|---|---|
|