Completed

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

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What is being tested

LeucoPatch treatment

Device
Who is being recruted

Cardiovascular Diseases+10

+ Diabetes Mellitus

+ Diabetic Angiopathies

Over 18 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2010
See protocol details

Summary

Principal SponsorReapplix
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2010

Actual date on which the first participant was enrolled.

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.

Official TitleLeucoPatch™ Study. A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
NCT01454401
Principal SponsorReapplix
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusDiabetic AngiopathiesDiabetic NeuropathiesEndocrine System DiseasesLeg UlcerSkin DiseasesSkin UlcerVascular DiseasesFoot UlcerSkin and Connective Tissue DiseasesDiabetic FootDiabetes Complications

Criteria

10 inclusion criteria required to participate
Written informed consent
Age > 18 years
Type I or Type II Diabetes
Age of wounds > 6 weeks
Show More Criteria
13 exclusion criteria prevent from participating
Non-Danish or Swedish speaking
Dementia
Pregnant or nursing women
The patient cannot tolerate blood donation
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Weekly treatment of diabetic foot ulcers with LeucoPatch

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

Knowledge Center for woundhealing, Bispebjerg Hospital

Copenhagen, DenmarkOpen Knowledge Center for woundhealing, Bispebjerg Hospital in Google Maps
Suspended

Steno Diabetes Center

Gentofte Municipality, Denmark
Suspended

Herlev Hospital, Orthopaedic Surgery Infirmary, Wound Clinic

Herlev, Denmark
Suspended

Vascular Center, Wound Clinic Kolding Hospital

Kolding, Denmark
Completed7 Study Centers