Venous Leg UlcerMINTNCT03670329
Management of Infection Risk in Non-comparative Trial (MINT)
A study testing URGO2875 in people with Venous Leg Ulcer, run by Laboratoires URGO.
Trial summary
The URGO2875 dressing is an innovative antimicrobial dressing made of exclusive technologies of TLC-Ag healing matrix and fibres. The dressing has been developed for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- URGO2875
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient, aged ≥ 18 years, who signed and dated informed consent form,
- Patients affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.7 and ≤ 1.3),
- Patient willing and able to wear an effective venous compression system every day during the study period,
- Patient with at least three of the five inflammatory clinical signs : pain between dressing changes, periwound erythema, local oedema, malodour and presence of heavy exudate.
Who cannot join
- Patients under guardianship or protection of vulnerable adult
- Pregnancy or breastfeeding women,
- Childbearing potential women with no medically-acceptable method of birth control,
- Patients included in another clinical study,
- Patients with known allergy with hydrocolloid (carboxymethylcellulose CMC), silicone or silver,
- Patients with wound covered partially or totally with necrotic tissue,
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- Patients who had within the 3 months prior the inclusion, deep vein thrombosis
- Patients with a serious general disease that deemed to interfere with the treatment period and evaluation
- Patients with progressive neoplastic lesions treated by radiotherapy, chemotherapy or hormone therapy
- Patients with non-controlled systemic infection by an suitable antibiotic therapy
- Patients with clinically infected wound
- Patients with wound requiring surgical treatment or for which surgery is scheduled during the study period
- Patients with known cancerous lesions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Acceptability of URGO2875 Dressing in the Treatment of Leg Ulcers With Inflammatory Signs
The URGO2875 dressing is an innovative antimicrobial dressing made of exclusive technologies of TLC-Ag healing matrix and fibres. The dressing has been developed for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection.
The purpose of this non-comparative clinical trial was to evaluate the performance (efficacy and safety) of the URGO2875 dressing, on the healing process of chronic wounds presenting a high-risk of infection.
Read the detailed description
The URGO2875 dressing is indicated for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection.
- Conditions
- Venous Leg Ulcer
- Being tested
- URGO2875
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URGO2875Device
Dressing
| Study group | Role | What they receive |
|---|---|---|
| URGO2875 | Experimental | Dressing Receives: Device: URGO2875 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound surface area
Relative wound surface area reduction (%) at the end of the four weeks of treatment
Measured: 4 weeks
Secondary outcomes (5)
Inflammatory clinical signs
The decrease of the clinical score, based on the presence of the five inflammatory clinical signs,
Measured: 4 weeks
Percentage of wounds with a favourable outcome
Defined as a relative wound area reduction of at least 40% after the 4-week treatment period
Measured: 4 weeks
Time to healing
Wound Healing time in days
Measured: 4 weeks
Healing
Percentage of Healing wound
Measured: 4 weeks
Patient quality of life
Patient quality of life assessed with EuroQoL 5D-5L
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study startOct 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg 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
- Not applicable
- Intervention model
- Single group
- Model description
- Non-comparative study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires URGO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GERI Ms Chloe, MD, Principal investigator, Lapeyronie Hospital, Montpellier- FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670329
- Sponsor's protocol ID
- F-08-07-AWC008
- Acronym
- MINT
- Status last verified
- Aug 2018
- First submitted
- 12 Sep 2018
- Last updated
- 13 Sep 2018
- 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 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Acceptability of URGO2875 Dressing in the Treatment of Leg Ulcers With Inflammatory Signs
- ClinicalTrials.gov ID
- NCT03670329
- Acronym / sponsor ID
- MINT / F-08-07-AWC008
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Laboratoires URGOIndustry (pharma, biotech, devices)
- Study start
- Oct 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 13 Sep 2018 (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.
The URGO2875 dressing is an innovative antimicrobial dressing made of exclusive technologies of TLC-Ag healing matrix and fibres. The dressing has been developed for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection.
The purpose of this non-comparative clinical trial was to evaluate the performance (efficacy and safety) of the URGO2875 dressing, on the healing process of chronic wounds presenting a high-risk of infection.
Detailed description
The URGO2875 dressing is indicated for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-comparative study
| Arm | Type | Receives |
|---|---|---|
| URGO2875 | Experimental | Device: URGO2875Dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient, aged ≥ 18 years, who signed and dated informed consent form,
- Patients affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.7 and ≤ 1.3),
- Patient willing and able to wear an effective venous compression system every day during the study period,
- Patient with at least three of the five inflammatory clinical signs : pain between dressing changes, periwound erythema, local oedema, malodour and presence of heavy exudate.
Key exclusion criteria (13 listed)
- Patients under guardianship or protection of vulnerable adult
- Pregnancy or breastfeeding women,
- Childbearing potential women with no medically-acceptable method of birth control,
- Patients included in another clinical study,
- Patients with known allergy with hydrocolloid (carboxymethylcellulose CMC), silicone or silver,
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 |
|---|---|---|
| URGO2875Dressing | Device | URGO2875 |
Primary outcome
Wound surface area
Time frame: 4 weeks
Relative wound surface area reduction (%) at the end of the four weeks of treatment
5 secondary outcomes
Inflammatory clinical signs
Time frame: 4 weeks
Percentage of wounds with a favourable outcome
Time frame: 4 weeks
Time to healing
Time frame: 4 weeks
Healing
Time frame: 4 weeks
Patient quality of life
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Individual participant dataSharing planned: No
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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.
GERI Ms Chloe, MD principal investigator
Lapeyronie Hospital, Montpellier- FRANCE
Questions about this trial
What is this clinical trial studying?
A study testing URGO2875 in people with Venous Leg Ulcer, run by Laboratoires URGO.
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 4 inclusion and 13 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 BATOT Ms Geraldine, PhD (+33 (0)3 80 44 28 46, g.batot@fr.urgo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound surface area (time frame: 4 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 13 Sep 2018.