NCT03736941

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Fondation Hôpital Saint-Joseph · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The supra-malleolar leg ulcers of venous origin, in the C6 stage of the CEAP (unhealed venous ulcer), are characterized by the presence of two pulses (pedis and posterior tibial) or a Systolic Pressure Index (SPI) ≥ 0, 7 or a pressure of the big toe ≥ 60 mmHg or an arterial echo-doppler of the lower limbs revealing neither hemodynamic stenosis nor arterial occlusion. The HAS working group defines a pure venous ulcer as a leg wound that has not healed for more than 1 month, related to an ambulatory venous hyperpressure. This hyperpressure may be secondary to superficial vein reflux and / or deep vein reflux or obstruction and / or calf pump deficiency. In the pure venous ulcer, there is no arterial involvement. The predominantly venous mixed ulcer is an ulcer with a preferentially venous mechanism but accompanied by a moderate arterial occlusion of the lower limbs which does not explain the symptomatology alone. The fundamental element in the management of venous or predominantly venous leg ulcers with an SPI\> 0.8 is venous compression as recommended by the June 2006 HAS. Numerous clinical evidence confirms its importance for improving the chances of closure of this chronic lesion and shortening the healing time compared to the absence of compression. It is a long treatment that can last several months, very restrictive for the patient and all the more so, that the perception of an improvement is far from immediate. In addition, the affected population is usually elderly, and the ulcer is a source of permanent discomfort, affecting the quality of life of the subjects and explaining frequent social isolation and depressed mood. Moreover, the cost of this treatment is sometimes dissuasive with a dependent burden for the patient who, sometimes, is unacceptable. 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 of the CEAP classification (ie not healed) with a systolic pressure index greater than 0,9 '. This type of device has demonstrated an efficiency of the same order as the multi-type or multi-band systems for the closure of venous ulcers. The investigators can therefore hope for the use of this type of stockings, a simplification of the care, an improvement of the comfort of wearing and thus a reduction of the feeling of frustration on the part of the patients with main consequence a better acceptability.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
OTHER	Patients with venous leg	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.

Timeline

• Start date: 2019-04-16
• Primary completion: 2022-04-15
• Completion: 2023-12-31
• First posted: 2018-11-09
• Last updated: 2023-04-27

Locations

2 sites across 1 country: France