Clinical Evaluation in Real Life of TLC-NOSF Dressings in the Local Treatment of Chronic Wounds (DFU and VLU) (STARTLIFE)

November 13, 2023 updated by: Laboratoires URGO

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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®

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Hemorrhagic wound
  • Cancerous wound
  • Fistulous wound revealing a deep abscess
  • Presence of dry necrosis partially or completely covering the wound bed
  • Infected wound
  • Osteitis
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to wound closure
Time Frame: 12 weeks
For healed patients: time to wound closure (in days)
12 weeks
Relative reduction in wound surface area
Time Frame: 12 weeks
Relative reduction in wound surface area (in %) during intermediate and final visits
12 weeks
EQ5D5L quality of life questionnaire
Time Frame: 12 weeks
The evolution of the patient quality of life assessed with the EuroQoL 5D-5L will be evaluated between baseline and at last visit.
12 weeks
Tolerance : the nature and number of adverse event related to the use of the testing dressings
Time Frame: 12 weeks
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.
12 weeks
Defectuosity of the device
Time Frame: 12 weeks
Description of the defects of the devices used.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires URGO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Estimated)

November 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A02414-37

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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