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

NCT01454401 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-24

Study results available
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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

Interventions

DEVICE

LeucoPatch treatment

weekly

Sponsors & Collaborators

  • Reapplix

    lead OTHER

Principal Investigators

  • Tonny Karlsmark, MD · Dept. of Dermatology D, Bispebjerg Hospital,

  • Bo Joergensen, MD · Dept. of Dermatology D, Bispebjerg Hospital,Denmark

  • Anna Marie Nielsen, MD · University Center for Wound Healing, Odense University Hospital, Denmark

  • Lise Tarnow, MD,MDSc · Steno Diabetes Center, Niels Steensensvej 2, 2820 Gentofte, Denmark

  • Mariusz Zakrzewski, MD · Vascular Center, wound clinic,Kolding Hospital, Skovvangen 2-8,6000 Kolding, Denmark

  • Niels Ejskjær, MD. PhD · Medical Endocrinology, Aarhus University Hospital, 8000 AArhuc C, Denmark

  • Morten Michelsen, MD · Orthopaedic Surgery, Sårcenter. Herlev Hospital, 2730 Herlev, Denmark

  • Magnus Löndahl, MD. PhD · Skane Hospital, Dept Endocrinology, Diabetes Foot Ulcer Clinic, Getingevägen 4, Lund, Sweden

  • Anders Nilsson, MD · Ängelholm Hospital, Diabetes Foot Ulcer Clinic, 262 81 Ängelholm Sweden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-10-31
Completion
2013-01-31

Countries

  • Denmark
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01454401 on ClinicalTrials.gov