LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01454401
Recruitment Status : Completed
First Posted : October 19, 2011
Results First Posted : October 6, 2016
Last Update Posted : October 6, 2016
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetic Foot Ulcers
Intervention: Device: LeucoPatch treatment

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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 10 cm2, n=1 amputation n=1 withdrawn consent, n=2 Osteomyelitis n=1 wrongly included n=2

Reporting Groups
LeucoPatch Treatment of Diabetic Foot Ulcers Weekly LeucoPatch treatment of diabetic foot ulcers

Participant Flow:   Overall Study
    LeucoPatch Treatment of Diabetic Foot Ulcers
STARTED   44 [1] 
COMPLETED   39 [2] 
Death                1 
hospitalised                1 
osteomyelitis                2 
non-adherence                1 
[1] ITT
[2] Per Protocol (PP)

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
LeucoPatch Treatment of Diabetic Foot Ulcers

Weekly treatment

LeucoPatch device: weekly treatment

Baseline Measures
   LeucoPatch Treatment of Diabetic Foot Ulcers 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   24 
>=65 years   20 
[Units: Years]
Median (Inter-Quartile Range)
All   63 
 (58 to 73) 
[Units: Participants]
Female   9 
Male   35 
[Units: Participants]
Type 1   8 
Type 2   36 
Body Mass Index (kg/m2) 
[Units: Kg/m^2]
Median (Inter-Quartile Range)
 (25.6 to 32.5) 
Presence of neuropathy 
[Units: Participants]
Yes   42 
No   2 
Ulcer duration (weeks) 
[Units: Weeks]
Median (Inter-Quartile Range)
 (16 to 60) 
Ulcer area 
[Units: Cm^2]
Median (Inter-Quartile Range)
 (0.5 to 2.9) 
Wagner classification [1] 
[Units: Participants]
Wagner grade 1   19 
Wagner grade 2   25 
[1] 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).
Biochemistry Haemoglobin 
[Units: G/l]
Median (Inter-Quartile Range)
 (114 to 139) 
[Units: 10^9 cells/l]
Median (Inter-Quartile Range)
Platelets   262 
 (225 to 330) 
Leucocytes   8.0 
 (6.2 to 10.1) 
[Units: %]
Median (Inter-Quartile Range)
 (6.2 to 10.1) 
[Units: Mmol/mol]
Median (Inter-Quartile Range)
 (55 to 79) 

  Outcome Measures

1.  Primary:   Ulcer Healing Within 20 Weeks   [ Time Frame: 20 weeks ]

2.  Secondary:   Ulcer Healing Within 12 Weeks.   [ Time Frame: 12 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: MD, PhD Senior Consultant Magnus Löndahl
Organization: Reapplix Blokken 45 3460 Birkerød Denmark

Responsible Party: Reapplix Identifier: NCT01454401     History of Changes
Other Study ID Numbers: H-4-2010-090
First Submitted: October 14, 2011
First Posted: October 19, 2011
Results First Submitted: May 17, 2016
Results First Posted: October 6, 2016
Last Update Posted: October 6, 2016