Clinical trial NCT03736941: Impact of Venotrain UlcerteC Venous Compression Device in the Treatment of Venous Ulcers in Daily Practice
Official title: Impact of Venotrain UlcerteC Venous Compression Device in the Treatment of Venous Ulcers in Daily Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Leg Ulcer
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 to be hospitalized within 20 weeks after inclusion
* 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

Primary outcomes:
measure: Prevalence of Optimal efficiency
timeFrame: Week 20
Secondary outcomes:
measure: health-related quality of life EQ5D-5L
timeFrame: Week 4
measure: health-related quality of life EQ5D-5L
timeFrame: Week 16
measure: health-related quality of life EQ5D-5L
timeFrame: Week 20
measure: Prevalence of acceptable efficiency
timeFrame: Week 20
measure: Evaluation of the patient's adhesion of VENOTRAIN® Ulcertec compressive sock
timeFrame: Week 4
measure: Evaluation of the patient's adhesion of VENOTRAIN® Ulcertec compressive sock
timeFrame: Week 16
measure: Evaluation of the patient's adhesion of VENOTRAIN® Ulcertec compressive sock
timeFrame: Week 20
measure: Time's estimation to obtain complete closure
timeFrame: Week 20
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre hospitalier universitaire d'Angers
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Audrey P STANSAL, MD
role: PRINCIPAL_INVESTIGATOR
References: