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

NCT01454401 | Completed Results DMC

• 1 other identifier: H-4-2010-090
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 7

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.

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ulcer Healing Within 12 Weeks.

  12 weeks

Study Arms (1)

Weekly LeucoPatch treatment

OTHER

Weekly treatment of diabetic foot ulcers with LeucoPatch

Device: LeucoPatch treatment

Interventions

LeucoPatch treatment DEVICE

weekly

Weekly LeucoPatch treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• % 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.

Sponsors & Collaborators

• Reapplix: lead

Study Sites (7)

Knowledge Center for woundhealing, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Location

Herlev Hospital, Orthopaedic Surgery Infirmary, Wound Clinic

Herlev, 2730, Denmark

Location

Vascular Center, Wound Clinic Kolding Hospital

Kolding, 6000, Denmark

Location

University center for woundhealing, Odense Hospital

Odense, 5000, Denmark

Location

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

Ängelholm, 262 81, Sweden

Location

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

Lund, Sweden

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: MD, PhD Senior Consultant Magnus Löndahl
• Organization: Reapplix Blokken 45 3460 Birkerød Denmark

magnus.londahl@med.lu.se

Study Officials

• Tonny Karlsmark, MD

  Dept. of Dermatology D, Bispebjerg Hospital,

  PRINCIPAL INVESTIGATOR

• Bo Joergensen, MD

  Dept. of Dermatology D, Bispebjerg Hospital,Denmark

  STUDY DIRECTOR

• Anna Marie Nielsen, MD

  University Center for Wound Healing, Odense University Hospital, Denmark

  STUDY DIRECTOR

• Lise Tarnow, MD,MDSc

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

  STUDY DIRECTOR

• Mariusz Zakrzewski, MD

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

  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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: October 19, 2011
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2013
• Last Updated: April 24, 2023
• Results First Posted: October 6, 2016

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5); SE (2)