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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

October 14, 2011
August 15, 2016
October 2010
October 2012   (final data collection date for primary outcome measure)
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.
The primary endpoint is time to complete healing. [ Time Frame: 20 weeks from treatmenstart ] [ Designated as safety issue: No ]
Treatment will be performed weekly
Complete list of historical versions of study NCT01454401 on ClinicalTrials.gov Archive Site
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
the secondary endpoint is change in wound size [ Time Frame: 20 weeks from treatment start ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
LeucoPatch™ Study. A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Foot Ulcers
Device: LeucoPatch treatment
weekly
Weekly LeucoPatch treatment
Weekly treatment of diabetic foot ulcers with LeucoPatch
Intervention: Device: LeucoPatch treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2013
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Sweden
 
NCT01454401
H-4-2010-090
Yes
No
Not Provided
Reapplix
Reapplix
Not Provided
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
Reapplix
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP