Clinical trial NCT01454401: LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
Official title: LeucoPatch™ Study. A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcers
Lead sponsor: Reapplix
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Ulcer Healing Within 20 Weeks
timeFrame: 20 weeks
Secondary outcomes:
measure: Ulcer Healing Within 12 Weeks.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Knowledge Center for woundhealing, Bispebjerg Hospital
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
city: Herlev
country: Denmark
facility: Herlev Hospital, Orthopaedic Surgery Infirmary, Wound Clinic
city: Kolding
country: Denmark
facility: Vascular Center, Wound Clinic Kolding Hospital
city: Odense
country: Denmark
facility: University center for woundhealing, Odense Hospital
city: Lund
country: Sweden
facility: Skane University Hospital, Dept. of Endocrinology, Diabetes Foot Ulcer Clinic
city: Ängelholm
country: Sweden
facility: Ängelholm Hospital, Dept. of Medicine, Diabetic Foot Ulcer Clinic
Study officials:
affiliation: Dept. of Dermatology D, Bispebjerg Hospital,
name: Tonny Karlsmark, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Dermatology D, Bispebjerg Hospital,Denmark
name: Bo Joergensen, MD
role: STUDY_DIRECTOR
affiliation: University Center for Wound Healing, Odense University Hospital, Denmark
name: Anna Marie Nielsen, MD
role: STUDY_DIRECTOR
affiliation: Steno Diabetes Center, Niels Steensensvej 2, 2820 Gentofte, Denmark
name: Lise Tarnow, MD,MDSc
role: STUDY_DIRECTOR
affiliation: Vascular Center, wound clinic,Kolding Hospital, Skovvangen 2-8,6000 Kolding, Denmark
name: Mariusz Zakrzewski, MD
role: STUDY_DIRECTOR
affiliation: Medical Endocrinology, Aarhus University Hospital, 8000 AArhuc C, Denmark
name: Niels Ejskjær, MD. PhD
role: STUDY_DIRECTOR
affiliation: Orthopaedic Surgery, Sårcenter. Herlev Hospital, 2730 Herlev, Denmark
name: Morten Michelsen, MD
role: STUDY_DIRECTOR
affiliation: Skane Hospital, Dept Endocrinology, Diabetes Foot Ulcer Clinic, Getingevägen 4, Lund, Sweden
name: Magnus Löndahl, MD. PhD
role: STUDY_DIRECTOR
affiliation: Ängelholm Hospital, Diabetes Foot Ulcer Clinic, 262 81 Ängelholm Sweden
name: Anders Nilsson, MD
role: STUDY_DIRECTOR
References: