Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot Ulcers
DISCOVERY
1 other identifier
interventional
210
6 countries
6
Brief Summary
Evaluation of the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of DFUs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
July 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJanuary 17, 2019
January 1, 2019
2.4 years
March 30, 2017
January 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
% of Wound Area Regression (WAR), as a measure of efficacy
Efficacy of dressings with LU3103209 versus dressing without LU3103209
12 weeks
Study Arms (3)
LU3103209 Dose 1
EXPERIMENTALDressing with LU3103209 Dose 1
LU3103209 Dose 2
EXPERIMENTALDressing with LU3103209 Dose 2
No LU3103209
PLACEBO COMPARATORDressing without LU3103209
Interventions
Eligibility Criteria
You may qualify if:
- Male or female over 18 years old who has provided his/her written informed consent
- Patient with Type 1 or Type 2 diabetes mellitus with glycated haemoglobin (HbA1c) level ≤ 10%
- Inpatient or outpatient who can be monitored by the same investigating team throughout the entire study
- Patient who agrees to wear an off-loading system during the trial
- Diagnosis of peripheral neuropathy
- Patient with an adequate arterial perfusion of the affected limb, confirmed by ABPI and Toe Blood Pressure assessment
- DFU Grade 1-A or 2-A or 1-C or 2-C as defined by the University of Texas Diabetic Wound Classification System
- Target DFU surface area between 1 cm² to 10 cm², after debridement
- DFU present since less than 24 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Pr JIRKOVSKA
Prague, Czechia
Pr PETIT
Dijon, France
Pr PIAGGESI
Pisa, Italy
Dr KORZON
Gdansk, Poland
Pr LAZARO
Madrid, Spain
Pr EDMONDS
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2017
First Posted
April 12, 2017
Study Start
July 31, 2017
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
January 17, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share