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

NCT ID: NCT01454401

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-01-31

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.

Conditions

Diabetic Foot Ulcers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Weekly LeucoPatch treatment

Weekly treatment of diabetic foot ulcers with LeucoPatch

Group Type: OTHER

LeucoPatch treatment

Intervention Type: DEVICE

weekly

Interventions

LeucoPatch treatment

weekly

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reapplix

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tonny Karlsmark, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Dermatology D, Bispebjerg Hospital,

Bo Joergensen, MD

Role: STUDY_DIRECTOR

Dept. of Dermatology D, Bispebjerg Hospital,Denmark

Anna Marie Nielsen, MD

Role: STUDY_DIRECTOR

University Center for Wound Healing, Odense University Hospital, Denmark

Lise Tarnow, MD,MDSc

Role: STUDY_DIRECTOR

Steno Diabetes Center, Niels Steensensvej 2, 2820 Gentofte, Denmark

Mariusz Zakrzewski, MD

Role: STUDY_DIRECTOR

Vascular Center, wound clinic,Kolding Hospital, Skovvangen 2-8,6000 Kolding, Denmark

Niels Ejskjær, MD. PhD

Role: STUDY_DIRECTOR

Medical Endocrinology, Aarhus University Hospital, 8000 AArhuc C, Denmark

Morten Michelsen, MD

Role: STUDY_DIRECTOR

Orthopaedic Surgery, Sårcenter. Herlev Hospital, 2730 Herlev, Denmark

Magnus Löndahl, MD. PhD

Role: STUDY_DIRECTOR

Skane Hospital, Dept Endocrinology, Diabetes Foot Ulcer Clinic, Getingevägen 4, Lund, Sweden

Anders Nilsson, MD

Role: STUDY_DIRECTOR

Ängelholm Hospital, Diabetes Foot Ulcer Clinic, 262 81 Ängelholm Sweden

Locations

Knowledge Center for woundhealing, Bispebjerg Hospital

Copenhagen, , Denmark

Steno Diabetes Center

Gentofte Municipality, , 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, , Denmark

Ängelholm Hospital, Dept. of Medicine, Diabetic Foot Ulcer Clinic

Ängelholm, , Sweden

Skane University Hospital, Dept. of Endocrinology, Diabetes Foot Ulcer Clinic

Lund, , Sweden

Countries

Denmark; Sweden

Other Identifiers

H-4-2010-090

Identifier Type: -

Identifier Source: org_study_id