Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reapplix
ClinicalTrials.gov Identifier:
NCT01454401
First received: October 14, 2011
Last updated: August 15, 2016
Last verified: June 2016
Results First Received: May 17, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetic Foot Ulcers
Intervention: Device: LeucoPatch treatment

  Participant Flow
  Hide 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 10 cm2, n=1 amputation n=1 withdrawn consent, n=2 Osteomyelitis n=1 wrongly included n=2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
  Description
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] 
NOT COMPLETED   5 
Death                1 
hospitalised                1 
osteomyelitis                2 
non-adherence                1 
[1] ITT
[2] Per Protocol (PP)



  Baseline Characteristics
  Hide 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
  Description
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]
 44 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   24 
>=65 years   20 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 
All   63 
 (58 to 73) 
Gender 
[Units: Participants]
 
Female   9 
Male   35 
Diabetes 
[Units: Participants]
 
Type 1   8 
Type 2   36 
Body Mass Index (kg/m2) 
[Units: Kg/m^2]
Median (Inter-Quartile Range)
 29.7 
 (25.6 to 32.5) 
Presence of neuropathy 
[Units: Participants]
 
Yes   42 
No   2 
Ulcer duration (weeks) 
[Units: Weeks]
Median (Inter-Quartile Range)
 35 
 (16 to 60) 
Ulcer area 
[Units: Cm^2]
Median (Inter-Quartile Range)
 1.1 
 (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)
 126 
 (114 to 139) 
Biochemistry 
[Units: 10^9 cells/l]
Median (Inter-Quartile Range)
 
Platelets   262 
 (225 to 330) 
Leucocytes   8.0 
 (6.2 to 10.1) 
HbA1c 
[Units: %]
Median (Inter-Quartile Range)
 8.1 
 (6.2 to 10.1) 
HbA1c 
[Units: Mmol/mol]
Median (Inter-Quartile Range)
 65 
 (55 to 79) 


  Outcome Measures
  Show All 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
  Hide 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
  Hide 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
e-mail: magnus.londahl@med.lu.se



Responsible Party: Reapplix
ClinicalTrials.gov Identifier: NCT01454401     History of Changes
Other Study ID Numbers: H-4-2010-090
Study First Received: October 14, 2011
Results First Received: May 17, 2016
Last Updated: August 15, 2016
Health Authority: Denmark: Ethics Committee
Sweden: Regional Ethical Review Board