Diabetic Foot Ulcer, QoL Questionnaire, Real Life Study, TLC-NOSF Dressings, Venous Leg Ulcer
Conditions
Brief 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 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).
Interventions
DEVICETLC-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)
Sponsors
Laboratoires URGO
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with complete healed chronic wound (venous leg ulcer and Diabetic foot ulcer) at 12 weeks | 12 weeks | Complete ulcer closure (100% re-epithelialization) over 12 weeks of treatment with UrgoStart Plus® Border, UrgoStart Plus® pad and UrgoStart Interface® dressings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to wound closure | 12 weeks | For healed patients: time to wound closure (in days) |
| Relative reduction in wound surface area | 12 weeks | Relative reduction in wound surface area (in %) during intermediate and final visits |
| EQ5D5L quality of life questionnaire | 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. |
| Tolerance : the nature and number of adverse event related to the use of the testing dressings | 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. |
| Defectuosity of the device | 12 weeks | Description of the defects of the devices used. |
Countries
France
Contacts
Primary ContactAnne SAUVADET, PhD
Backup ContactOlivier TACCA, PhD
Outcome results
None listed