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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Device: LeucoPatch treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Knowledge Center for woundhealing, Bispebjerg Hospital
  • Gentofte, Denmark, 2820
    • Steno Diabetes Center
  • Herlev, Denmark, 2730
    • Herlev Hospital, Orthopaedic Surgery Infirmary, Wound Clinic
  • Kolding, Denmark, 6000
    • Vascular Center, Wound Clinic Kolding Hospital
  • Odense, Denmark, 5000
    • University center for woundhealing, Odense Hospital
• Sweden
  • Lund, Sweden
    • Skane University Hospital, Dept. of Endocrinology, Diabetes Foot Ulcer Clinic
  • Ängelholm, Sweden, 262 81
    • Ängelholm Hospital, Dept. of Medicine, Diabetic Foot Ulcer Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Weekly LeucoPatch treatment; Weekly treatment of diabetic foot ulcers with LeucoPatch	Device: LeucoPatch treatment; weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Reapplix
• Investigators: Study Director: Niels Ejskjær, MD. PhD, Medical Endocrinology, Aarhus University Hospital, 8000 AArhuc C, Denmark; Study Director: Morten Michelsen, MD, Orthopaedic Surgery, Sårcenter. Herlev Hospital, 2730 Herlev, Denmark; Study Director: Magnus Löndahl, MD. PhD, Skane Hospital, Dept Endocrinology, Diabetes Foot Ulcer Clinic, Getingevägen 4, Lund, Sweden; Study Director: Anders Nilsson, MD, Ängelholm Hospital, Diabetes Foot Ulcer Clinic, 262 81 Ängelholm Sweden

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 14, 2011
• First Submitted That Met QC Criteria: October 18, 2011
• First Posted (Estimate): October 19, 2011

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: H-4-2010-090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO