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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
  Purpose
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 Intervention Phase
Diabetic Foot Ulcers
Device: LeucoPatch treatment
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LeucoPatch™ Study. A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by Reapplix:

Primary Outcome Measures:
  • Ulcer Healing Within 20 Weeks [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population.


Secondary Outcome Measures:
  • Ulcer Healing Within 12 Weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population


Enrollment: 60
Study Start Date: October 2010
Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Weekly LeucoPatch treatment
Weekly treatment of diabetic foot ulcers with LeucoPatch
Device: LeucoPatch treatment
weekly

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454401

Locations
Denmark
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
Sweden
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
Reapplix
Investigators
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
  More Information

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
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetic Angiopathies
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases

ClinicalTrials.gov processed this record on December 07, 2016