Impact of Venotrain UlcerteC Venous Compression Device in the Treatment of Venous Ulcers in Daily Practice

NCT03736941 | Unknown

• 1 other identifier: INVICTUS
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 2

Brief Summary

The cornerstone of the management of venous leg or predominantly venous leg ulcers with IPS\> 0.8 is venous compression as recommended by the HAS in June 2006. There is ample clinical evidence to support its importance to improve the chances of closure of this chronic lesion and shorten the healing time compared to the absence of compression. In 2016, a system of re-usable compression stockings (Venotrain® Ulcertec, BAUERFEIND, France), and bringing an interface pressure of 30 to 45 mmHg to the ankle according to the prescription, was taken over by the Health Insurance in France. 'Indication' Ulcer of venous origin or predominantly venous component, stage C6 CEAP classification with a systolic pressure index greater than 0.9 '. The investigators propose to study the efficiency of Venotrain® Ulcertec in a diverse population in which it is prescribed according to the usual practices of venous leg ulceration of venous or predominantly venous origin.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Prevalence of Optimal efficiency

  The primary endpoint is the overall, center-level prevalence of optimal VENOTRAIN® Ulcertec compressive sock efficiency. Optimal efficiency is defined by the observation of an ulcer closure at the end of a maximum follow-up of 20 weeks without the need to change the type of compression system initially prescribed and without detecting local problems considered by the clinician as possibly related to the compressive device but not interfering with the patient's management.

  Week 20

Secondary Outcomes (8)

• health-related quality of life EQ5D-5L

  Week 4

• health-related quality of life EQ5D-5L

  Week 16

• health-related quality of life EQ5D-5L

  Week 20

• Prevalence of acceptable efficiency

  Week 20

• Evaluation of the patient's adhesion of VENOTRAIN® Ulcertec compressive sock

  Week 4

Study Arms (1)

Patients with venous leg

EXPERIMENTAL

After inclusion, the medical device Venotrain® Ulcertec will be prescribed according to the indications supported by the Health Insurance and used according to the recommendations of the manufacturer. Follow-up visits are scheduled at 4, and 16 weeks (± 1 week) as well as an end-of-study visit, not later than 20 weeks after enrollment or in case of premature termination. follow-up. During the various visits, clinical data will be collected in the patient's medical file as well as the answers to the questionnaires.

Other: Patients with venous leg

Interventions

Patients with venous leg OTHER

The medical device Venotrain® Ulcertec will be prescribed according to the indications supported by the Health Insurance and used according to the recommendations of the manufacturer. It will be dispensed in town pharmacies. After inclusion, follow-up visits are scheduled at 4, and 16 weeks (± 1 week) as well as an end-of-study visit, not later than 20 weeks after enrollment or in case of premature termination. follow-up.

Patients with venous leg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient whose age is ≥ 18 years
• Patient with venous or predominantly venous leg ulcer as defined by HAS
• Patient with at least one supracleolar ulcer at stage C6 of CEAP
• Surface of the ulcer of the largest size ≤ 10 cm2
• IPS less than 6 months\> 0.8 for both limbs or toe pressure ≥ 60 mmHg if mediacalcosis (SPI\> 1.2)
• Patient with a maximum of three supraballeolar ulcers (one or two sided)
• Patient followed by a hospital outpatient clinic in the departments of vascular medicine, angiology, internal medicine, dermatology or geriatric medicine (First consultation or not)
• Patient with walking ability over 50 m (with or without help)
• Patient with a prescription indication of Venetrain® Ulcertec Low Venous Compression System (Bauerfeind)
• Patient giving free, informed and written consent

You may not qualify if:

• Any other non-venous etiology of the ulcer in the opinion of the clinician
• Infections of lesions requiring the introduction of systemic antibiotic therapy
• Contraindication to treatment including venous compression by stockings
• Patient with cognitive impairment
• Patient with another wound than the leg ulcer (s) (especially foot ulcers, pressure ulcers)
• Patient with at least one very exudative ulcer, requiring the placement of a thick absorbent primary dressing incompatible with the use of compression stockings

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (2)

Centre hospitalier universitaire d'Angers

Angers, 49100, France

Location

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Audrey P STANSAL, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 9, 2018
• Study Start: April 16, 2019
• Primary Completion: April 15, 2022
• Study Completion: December 31, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (2)