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

Diabetic Foot Ulcer Clinical Trial

— STARTLIFE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135987
• Other study ID #: 2021-A02414-37
• Status: Recruiting
• Start date: June 24, 2022
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Laboratoires URGO
• Contact: Anne SAUVADET, PhD
• Phone: +33380442884
• Email: a.sauvadet[@]fr.urgo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 conditions and current practice, in France.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• 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)

Locations

Country	Name	City	State
France	Pr Agnès HARTEMANN	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires URGO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks
Secondary	Time to wound closure	For healed patients: time to wound closure (in days)	12 weeks
Secondary	Relative reduction in wound surface area	Relative reduction in wound surface area (in %) during intermediate and final visits	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	Defectuosity of the device	Description of the defects of the devices used.	12 weeks