LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers

Diabetic Foot Ulcers Clinical Trial

Official title:

LeucoPatch™ Study. A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454401
• Other study ID #: H-4-2010-090
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: January 2013

Study information

• Verified date: March 2023
• Source: Reapplix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Device:
• LeucoPatch treatment
weekly

Locations

Country	Name	City	State
Denmark	Knowledge Center for woundhealing, Bispebjerg Hospital	Copenhagen
Denmark	Steno Diabetes Center	Gentofte
Denmark	Herlev Hospital, Orthopaedic Surgery Infirmary, Wound Clinic	Herlev
Denmark	Vascular Center, Wound Clinic Kolding Hospital	Kolding
Denmark	University center for woundhealing, Odense Hospital	Odense
Sweden	Ängelholm Hospital, Dept. of Medicine, Diabetic Foot Ulcer Clinic	Ängelholm
Sweden	Skane University Hospital, Dept. of Endocrinology, Diabetes Foot Ulcer Clinic	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Reapplix

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ulcer Healing Within 20 Weeks	Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population.	20 weeks
Secondary	Ulcer Healing Within 12 Weeks.	Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population	12 weeks