Real Life StudySTARTLIFENCT06135987
Clinical Evaluation in Real Life of TLC-NOSF Dressings in the Local Treatment of Chronic Wounds (DFU and VLU)
An observational study of Real Life Study and TLC-NOSF Dressings, run by Laboratoires URGO at 1 site in France.
Trial summary
The objective of this study is to document the performance and the safety of UrgoStart Plus® Border, UrgoStart Plus® Pad and UrgoStart Interface® in the local treatment of diabetic foot ulcers (neuropathic or neuroischemic - non-critical ischemia) and venous or mixed predominantly venous leg ulcers, in real life… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Real Life Study, TLC-NOSF Dressings, Venous Leg Ulcer
- What is being tested?
- TLC-NOSF dressings (D'URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE®)
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2022to Oct 2024
- Phase
- Observational
- 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
Study population: Patients participating in this clinical evaluation suffering of: * a predominantly venous or mixed leg ulcer, * or a neuropathic or neuroischemic diabetic foot ulcer (without critical ischemia) that the investigating physician has decided to treat with one or other of the 3 following dressing containing TLC-NOSF : UrgoStart Plus® Border, UrgoStart Plus® Pad or UrgoStart Interface®
Who may be able to join
- Adult outpatient having signed informed consent
- Patient with a venous leg ulcer (VLU) Or with a diabetic foot ulcer (DFU)
- Prescription of one of the 3 dressings: UrgoStart Plus® Border, UrgoStart Plus® pad or UrgoStart Interface®
- Patient can be followed over 12 weeks by the investigator, according to his/her practices
- Patient able to participate in the study and complete a self-questionnaire without difficulty
Who cannot join
- Hemorrhagic wound
- Cancerous wound
- Fistulous wound revealing a deep abscess
- Presence of dry necrosis partially or completely covering the wound bed
- Infected wound
- Osteitis
Show all 11Show fewer
- Critical or acute ischemia
- Patient for whom a surgical procedure related to the treated wound is scheduled within 12 weeks following the inclusion visit
- Patient with known sensitivity to one of the studied dressings components
- Pregnant or breastfeeding patient
- Patient under the protection of justice or under guardianship or deprived of liberty
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Pr Agnès HARTEMANN
Paris, 75000
Anne SAUVADET, PhD, +33671197891, a.sauvadet@fr.urgo.com
Olivier TACCA, pHD, +33380447422, o.tacca@fr.urgo.com
About this study
Official title: Clinical Evaluation of URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE® in the Local Treatment of Diabetic Foot Ulcers and Venous Leg Ulcer of Mixed Etiology : French Prospective and Multicentric Observational Study
The objective of this study is to document the performance and the safety of UrgoStart Plus® Border, UrgoStart Plus® Pad and UrgoStart Interface® in the local treatment of diabetic foot ulcers (neuropathic or neuroischemic - non-critical ischemia) and venous or mixed predominantly venous leg ulcers, in real life conditions and current practice, in France.
Read the detailed description
This is an observational, non-interventional, prospective multicenter study, carried out in real-life conditions on CE marked medical devices used for their intended purpose.
The study will be carried out in France, in accordance with national and European regulations (RDM 2017/745).
- Conditions
- Real Life Study, TLC-NOSF Dressings, Venous Leg Ulcer, Diabetic Foot Ulcer, QoL Questionnaire
- Being tested
- TLC-NOSF dressings (D'URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE®)
- Medical subject headings
- Varicose Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC-NOSF dressings (D'URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE®)Device
Clinical evaluation of the dressing in the local treatment of chronic wounds (DFU and VLU)
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with complete healed chronic wound (venous leg ulcer and Diabetic foot ulcer) at 12 weeks
Complete ulcer closure (100% re-epithelialization) over 12 weeks of treatment with UrgoStart Plus® Border, UrgoStart Plus® pad and UrgoStart Interface® dressings
Measured: 12 weeks
Secondary outcomes (5)
Time to wound closure
For healed patients: time to wound closure (in days)
Measured: 12 weeks
Relative reduction in wound surface area
Relative reduction in wound surface area (in %) during intermediate and final visits
Measured: 12 weeks
EQ5D5L quality of life questionnaire
The evolution of the patient quality of life assessed with the EuroQoL 5D-5L will be evaluated between baseline and at last visit.
Measured: 12 weeks
Tolerance : the nature and number of adverse event related to the use of the testing dressings
The nature and number of adverse event related to the use of the testing dressings (UrgoStart Plus® Border, UrgoStart Plus® pad and UrgoStart Interface® dressings) (serious/ non-serious) will be described.
Measured: 12 weeks
Defectuosity of the device
Description of the defects of the devices used.
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 posted18 Nov 2023
- Study start24 Jun 2022
- Primary completionJun 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Real Life StudyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 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
- NCT06135987
- Sponsor's protocol ID
- 2021-A02414-37
- Acronym
- STARTLIFE
- Status last verified
- Nov 2023
- First submitted
- 16 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leger P, Malloizel-Delaunay J, Moreau J, Michon-Pasturel U, Bouillet B, Sultan A, Schulidner S, Dardari D, Haase-Ruby C, Sauvadet A, Doan J, Hartemann A, Meaume S, Colboc H. Managing chronic wounds with TLC-NOSF dressings: evidence from a prospective real-life patient cohort. J Wound Care. 2026 Aug 2;35(8):662-672. doi: 10.12968/jowc.2026.0087. Epub 2026 Aug 10.
PubMed 42574339
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE® in the Local Treatment of Diabetic Foot Ulcers and Venous Leg Ulcer of Mixed Etiology : French Prospective and Multicentric Observational Study
- ClinicalTrials.gov ID
- NCT06135987
- Acronym / sponsor ID
- STARTLIFE / 2021-A02414-37
- Conditions
- Real Life Study, TLC-NOSF Dressings, Venous Leg Ulcer, Diabetic Foot Ulcer, QoL Questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Laboratoires URGOIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 18 Nov 2023 (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 objective of this study is to document the performance and the safety of UrgoStart Plus® Border, UrgoStart Plus® Pad and UrgoStart Interface® in the local treatment of diabetic foot ulcers (neuropathic or neuroischemic - non-critical ischemia) and venous or mixed predominantly venous leg ulcers, in real life conditions and current practice, in France.
Detailed description
This is an observational, non-interventional, prospective multicenter study, carried out in real-life conditions on CE marked medical devices used for their intended purpose.
The study will be carried out in France, in accordance with national and European regulations (RDM 2017/745).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients participating in this clinical evaluation suffering of: * a predominantly venous or mixed leg ulcer, * or a neuropathic or neuroischemic diabetic foot ulcer (without critical ischemia) that the investigating physician has decided to treat with one or other of the 3 following dressing containing TLC-NOSF : UrgoStart Plus® Border, UrgoStart Plus® Pad or UrgoStart Interface®
Key inclusion criteria (5 listed)
- Adult outpatient having signed informed consent
- Patient with a venous leg ulcer (VLU) Or with a diabetic foot ulcer (DFU)
- Prescription of one of the 3 dressings: UrgoStart Plus® Border, UrgoStart Plus® pad or UrgoStart Interface®
- Patient can be followed over 12 weeks by the investigator, according to his/her practices
- Patient able to participate in the study and complete a self-questionnaire without difficulty
Key exclusion criteria (11 listed)
- Hemorrhagic wound
- Cancerous wound
- Fistulous wound revealing a deep abscess
- Presence of dry necrosis partially or completely covering the wound bed
- Infected wound
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 |
|---|---|---|
| TLC-NOSF dressings (D'URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE®)Clinical evaluation of the dressing in the local treatment of chronic wounds (DFU and VLU) | Device | – |
Primary outcome
Number of patients with complete healed chronic wound (venous leg ulcer and Diabetic foot ulcer) at 12 weeks
Time frame: 12 weeks
Complete ulcer closure (100% re-epithelialization) over 12 weeks of treatment with UrgoStart Plus® Border, UrgoStart Plus® pad and UrgoStart Interface® dressings
5 secondary outcomes
Time to wound closure
Time frame: 12 weeks
Relative reduction in wound surface area
Time frame: 12 weeks
EQ5D5L quality of life questionnaire
Time frame: 12 weeks
Tolerance : the nature and number of adverse event related to the use of the testing dressings
Time frame: 12 weeks
Defectuosity of the device
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 42574339Leger P, Malloizel-Delaunay J, Moreau J, Michon-Pasturel U, Bouillet B, Sultan A, Schulidner S, Dardari D, Haase-Ruby C, Sauvadet A, Doan J, Hartemann A, Meaume S, Colboc H. Managing chronic wounds with TLC-NOSF dressings: evidence from a prospective real-life patient cohort. J Wound Care. 2026 Aug 2;35(8):662-672. doi: 10.12968/jowc.2026.0087. Epub 2026 Aug 10.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Real Life Study and TLC-NOSF Dressings, run by Laboratoires URGO at 1 site in France.
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 5 inclusion and 11 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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?
Number of patients with complete healed chronic wound (venous leg ulcer and Diabetic foot ulcer) at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06135987, which also lists 1 linked publication.
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 18 Nov 2023.