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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):

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Device: LeucoPatch treatment Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LeucoPatch™ Study. A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
Study Start Date : October 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Weekly LeucoPatch treatment
Weekly treatment of diabetic foot ulcers with LeucoPatch
Device: LeucoPatch treatment

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Ulcer Healing Within 12 Weeks. [ Time Frame: 12 weeks ]
    Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01454401

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Knowledge Center for woundhealing, Bispebjerg Hospital
Copenhagen, Denmark, 2400
Steno Diabetes Center
Gentofte, Denmark, 2820
Herlev Hospital, Orthopaedic Surgery Infirmary, Wound Clinic
Herlev, Denmark, 2730
Vascular Center, Wound Clinic Kolding Hospital
Kolding, Denmark, 6000
University center for woundhealing, Odense Hospital
Odense, Denmark, 5000
Skane University Hospital, Dept. of Endocrinology, Diabetes Foot Ulcer Clinic
Lund, Sweden
Ängelholm Hospital, Dept. of Medicine, Diabetic Foot Ulcer Clinic
Ängelholm, Sweden, 262 81
Sponsors and Collaborators
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Principal Investigator: Tonny Karlsmark, MD Dept. of Dermatology D, Bispebjerg Hospital,
Study Director: 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 Afd.M Endocrinology, Aarhus University Hospital,. Noerrebrogade 44,8000 Århuc C, Denmark
Study Director: Morten Michelsen, MD Orthopaedic Surgery Infirmary, Sårcenter. Herlev Hospital,Herlev Ringvej 75,2730 Herlev, Denmark
Study Director: Magnus Löndahl, MD. PhD Skane University Hospital, Department of Endocrinology, Diabetes Foot Ulcer Clinic, Hudhuset Getingevägen 4, Lund, Sweden
Study Director: Anders Nilsson, MD Ängelholm Hospital, Department of Medicine, Diabetes Foot Ulcer Clinic, 262 81 Ängelholm Sweden

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Responsible Party: Reapplix Identifier: NCT01454401     History of Changes
Other Study ID Numbers: H-4-2010-090
First Posted: October 19, 2011    Key Record Dates
Results First Posted: October 6, 2016
Last Update Posted: October 6, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases