Diabetic Foot UlcerDISCOVERYNCT03110796
Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot Ulcers
A study testing Dressing with LU3103209 - Dose 1, Dressing with LU3103209 - Dose 2 and Dressing without LU3103209 in people with Diabetic Foot Ulcer, run by Laboratoires URGO at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Dressing with LU3103209 - Dose 1, Dressing with LU3103209 - Dose 2 and Dressing without LU3103209
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 31 Jul 2017to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Pregnant or breast-feeding woman or woman of childbearing potential not protected by an effective contraceptive method of birth control B. Patient who participated in another clinical trial in the previous month or who will take part in another clinical trial during the 12 weeks following the inclusion C. Patient with severe renal impairment D. Patient who has presented, during the 3 months before inclusion, an acute ischemic event (acute myocardial infarction or stroke) E. Patient with an active neoplastic condition, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant F. Patient treated for a chronic disease requiring high doses of systemic corticosteroids on a daily basis (≥ 40 mg prednisolone) G. Patient with infection which is not controlled by a suitable antibiotic treatment H. Patient with any known allergy or reported adverse reaction to the trial device
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot Ulcers: a Prospective, Randomized, Controlled, Double-blind, European Multicentre Clinical Trial
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.
Read the detailed description
A European prospective, randomized, double-blind, multicentre, clinical trial, conducted in three parallel groups, to evaluate the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of diabetic foot ulcers (DFUs).
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Dressing with LU3103209 - Dose 1, Dressing with LU3103209 - Dose 2, Dressing without LU3103209
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dressing with LU3103209 - Dose 1Device
Dressing with LU3103209 - Dose 1
Dressing with LU3103209 - Dose 2Device
Dressing with LU3103209 - Dose 2
Dressing without LU3103209Device
Dressing without LU3103209
| Study group | Role | What they receive |
|---|---|---|
| LU3103209 Dose 1 | Experimental | Dressing with LU3103209 Dose 1 Receives: Device: Dressing with LU3103209 - Dose 1 |
| LU3103209 Dose 2 | Experimental | Dressing with LU3103209 Dose 2 Receives: Device: Dressing with LU3103209 - Dose 2 |
| No LU3103209 | Placebo comparator | Dressing without LU3103209 Receives: Device: Dressing without LU3103209 |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of Wound Area Regression (WAR), as a measure of efficacy
Efficacy of dressings with LU3103209 versus dressing without LU3103209
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start31 Jul 2017
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires URGO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110796
- Sponsor's protocol ID
- FI-16-03-310 3209
- Acronym
- DISCOVERY
- Status last verified
- Jan 2019
- First submitted
- 30 Mar 2017
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot Ulcers: a Prospective, Randomized, Controlled, Double-blind, European Multicentre Clinical Trial
- ClinicalTrials.gov ID
- NCT03110796
- Acronym / sponsor ID
- DISCOVERY / FI-16-03-310 3209
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Laboratoires URGOIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A European prospective, randomized, double-blind, multicentre, clinical trial, conducted in three parallel groups, to evaluate the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of diabetic foot ulcers (DFUs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LU3103209 Dose 1 | Experimental | Device: Dressing with LU3103209 - Dose 1Dressing with LU3103209 Dose 1 |
| LU3103209 Dose 2 | Experimental | Device: Dressing with LU3103209 - Dose 2Dressing with LU3103209 Dose 2 |
| No LU3103209 | Placebo comparator | Device: Dressing without LU3103209Dressing without LU3103209 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant or breast-feeding woman or woman of childbearing potential not protected by an effective contraceptive method of birth control B. Patient who participated in another clinical trial in the previous month or who will take part in another clinical trial during the 12 weeks following the inclusion C. Patient with severe renal impairment D. Patient who has presented, during the 3 months before inclusion, an acute ischemic event (acute myocardial infarction or stroke) E. Patient with an active neoplastic condition, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant F. Patient treated for a chronic disease requiring high doses of systemic corticosteroids on a daily basis (≥ 40 mg prednisolone) G. Patient with infection which is not controlled by a suitable antibiotic treatment H. Patient with any known allergy or reported adverse reaction to the trial device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dressing with LU3103209 - Dose 1Dressing with LU3103209 - Dose 1 | Device | LU3103209 Dose 1 |
| Dressing with LU3103209 - Dose 2Dressing with LU3103209 - Dose 2 | Device | LU3103209 Dose 2 |
| Dressing without LU3103209Dressing without LU3103209 | Device | No LU3103209 |
Primary outcome
% of Wound Area Regression (WAR), as a measure of efficacy
Time frame: 12 weeks
Efficacy of dressings with LU3103209 versus dressing without LU3103209
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Individual participant dataSharing planned: No
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dressing with LU3103209 - Dose 1, Dressing with LU3103209 - Dose 2 and Dressing without LU3103209 in people with Diabetic Foot Ulcer, run by Laboratoires URGO at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Czechia, France, Italy, Poland, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Sauvadet, PhD (+33380442884, a.sauvadet@fr.urgo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of Wound Area Regression (WAR), as a measure of efficacy (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2019.