NCT02958072

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

6.3 years

First QC Date

October 27, 2016

Last Update Submit

November 20, 2023

Conditions

Diabetic Malleoli UlcersMalleoli Ulcers

Keywords

Malleoli ulcersDiabetesHealingDressingLeucoPatch

Outcome Measures

Primary Outcomes (1)

  • Healing of malleoli ulcer (YES/NO)

    Confirmed by a blinded observer

    up to 24 weeks of treatment

Secondary Outcomes (6)

  • Time to healing of malleoli ulcer

    24 weeks

  • Ulcer area reduction based on Image J measured on acetate drawing

    24 weeks

  • Health related quality of life questionnaire SF12

    week 0, week 12, and week 24

  • Health related quality of life questionnaire EQ-5D

    week 0, week 12, and week 24

  • Pain at ulcer location

    week 0, week 6, week 12 and week 24

  • +1 more secondary outcomes

Study Arms (2)

LeucoPatch

EXPERIMENTAL

Treatment with usual ulcer care and LeucoPatch once weekly up til 24 weeks or until healing.

Other: LeucoPatch

Usual care followed by LeucoPatch

ACTIVE COMPARATOR

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

Interventions

LeucoPatchOTHER

LeucoPatch is an fully autologous growth factor-containing dressing

LeucoPatchUsual care followed by LeucoPatch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Bispebjerg hospital

Copenhagen, Capital Region, 2400, Denmark

Location

Viborg Sygehus

Viborg, Region Midt, 8800, Denmark

Location

Nordsjaellands Hospital

Hillerød, Regionh, 3400, Denmark

Location

Herlev-Gentofte Hospital

Herlev, Denmark

Location

Kolding Sygehus

Kolding, Denmark

Location

Skaane University Hospital

Lund, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lise Tarnow, Professsor

    Nordsjaellands Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2016

First Posted

November 8, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2023

Study Completion

November 1, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(5)SE(1)