NCT01454401

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Reapplix · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	LeucoPatch treatment	weekly

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-10-01
• Completion: 2013-01-01
• First posted: 2011-10-19
• Last updated: 2023-04-24
• Results posted: 2016-10-06

Locations

7 sites across 2 countries: Denmark, Sweden