LeucoPatch in Malleoli Ulcer Study (LiDMUS)

November 20, 2023 updated by: Nordsjaellands Hospital

An International Multicenter study evaluation, off the effect of the fully autologous growth factor-containing patch LeucoPatch, on healing of recalcitrant malleoli ulcers.

To compare the impact of LeucoPatch as part of usual care in multidisciplinary Foot clinic settings, versus usual care in the same clinics on malleoli ulcers healing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetic Foot Ulcers are a common and severe complication, that affects Patients Life Quality. Healing time is often long and the Diabetic foot ulcer is the dominating not traumatic reason for leg amputation.

Treatment of a diabetic foot ulcer requires debridement, offloading, regularly foot care, specially tailored shoes, antimicrobial treatment, and sometimes even surgical interventions. Despite all these interventions the diabetic foot ulcer may not heal.

Malleoli ulcers in patients without diabetes share several features of pathogenesis and lack of healing potentials with the Diabetic Ulcer. Like the features of pathogenesis and lack of healing potential and are therefore included in this study.

Research has shown that other methods such as Growth factors may be a way to enhance the chance of healing.

Growth Factors have been shown to have a positive effect in studies, but no products that are characterized as autologous have as yet obtained positive results in controlled studies.

LeucoPatch is produced solely from a patient´s own blood without addition, and is autologous. LeucoPatch appears as an elastic membrane and can be fitted to the individual ulcer.

LeucoPatch is shown to contain as many or more growth factors as existing products, and has a high concentration of fibrin, platelets and leukocytes.

A non-controlled study was made on ulcers less than 10cm 2 and 52% had competed epithelization after 20 weeks. An International randomized multicenter trial is ongoing to evaluate the efficacy and safety of LeucoPatch on healing of hard to heal diabetic foot ulcers below the malleoli.

This Study is designed to test the healing effect of the LeucoPatch on malleoli ulcers, the Patient will be randomized and the healing will be confirmed by a blinded observer.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark
        • Herlev-Gentofte Hospital
      • Kolding, Denmark
        • Kolding Sygehus
    • Region Hovedstaden
      • Kobenhavn, Region Hovedstaden, Denmark, 2400
        • Bispebjerg Hospital
    • Region Midt
      • Viborg, Region Midt, Denmark, 8800
        • Viborg Sygehus
    • Regionh
      • Hillerod, Regionh, Denmark, 3400
        • Nordsjaellands Hospital
  • Sweden
      • Lund, Sweden
        • Skaane University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Foot ulcer at the malleoli area between 0,25 cm² and 5,0 cm²
  • Foot ulcer duration more than 6 weeks
  • No need for arterial revascularisation- as judged by the Investigator
  • informed consent

Exclusion Criteria:

  • Hemoglobin concentration under 6.5 mmol/l screening
  • Non-compliant with blood-letting
  • Clinically infected ulcer
  • Patient planned for or has had a revascularization procedure in the affected leg within the last 8 weeks
  • The ulcer have been treated with growth factors in the last 8 weeks
  • History of deep venous insufficiency, chronic venous leg ulcer or stasis dermatitis
  • Breast-feeding women or fertile women not agreeing to use an effective method of contraception
  • Participation in another clinical ulcer-healing study within the last 4 weeks
  • Patient has previously been randomized in this study
  • Judgement by the investigator that the patient is not able to participate in the study

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LeucoPatch
Treatment with usual ulcer care and LeucoPatch once weekly up til 24 weeks or until healing.
Other: LeucoPatch
LeucoPatch is an fully autologous growth factor-containing dressing
Active Comparator: Usual care followed by LeucoPatch
Usual care weekly for 12 weeks, if the ulcer persist after the12 weeks LeucoPatch treatment will be started for up to 12 weeks or until healing.
Other: LeucoPatch
LeucoPatch is an fully autologous growth factor-containing dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing of malleoli ulcer (YES/NO)
Time Frame: up to 24 weeks of treatment
Confirmed by a blinded observer
up to 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to healing of malleoli ulcer
Time Frame: 24 weeks
Weeks from Inclusion to Wound healing
24 weeks
Ulcer area reduction based on Image J measured on acetate drawing
Time Frame: 24 weeks
24 weeks
Health related quality of life questionnaire SF12
Time Frame: week 0, week 12, and week 24
Short Form 12 questionnaire (quality of life)SF-12
week 0, week 12, and week 24
Health related quality of life questionnaire EQ-5D
Time Frame: week 0, week 12, and week 24
Euroquol-D5 questionnaire(mood and function) EQ-5D
week 0, week 12, and week 24
Pain at ulcer location
Time Frame: week 0, week 6, week 12 and week 24
VAS Score (Visual Analogue Scale)
week 0, week 6, week 12 and week 24
Z scores of combined plasma concentration of growth factors, cytokines and inflammatory markers
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordsjaellands Hospital

Collaborators

Skane University Hospital
Reapplix

Investigators

  • Study Director: Lise Tarnow, Professsor, Nordsjaellands Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimated)

November 8, 2016

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LiDMUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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