Status:
COMPLETED
LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
Lead Sponsor:
Reapplix
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01454401
Start Date
October 1 2010
End Date
January 1 2013
Last Update
April 24 2023
Active Locations (7)
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1
Knowledge Center for woundhealing, Bispebjerg Hospital
Copenhagen, Denmark, 2400
2
Steno Diabetes Center
Gentofte Municipality, Denmark, 2820
3
Herlev Hospital, Orthopaedic Surgery Infirmary, Wound Clinic
Herlev, Denmark, 2730
4
Vascular Center, Wound Clinic Kolding Hospital
Kolding, Denmark, 6000