Evaluation of the Safety of Compressive Socks to Treat Venous Insufficiency in Patients With Peripheral Arterial Disease

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Venous Insufficiency; Peripheral Arterial Disease

Treatments: Device: contention socks

Study type: Interventional

Funder types: Other

Identifiers

NCT02431819

1408064

Details and patient eligibility

About

Elastic compression stockings are recommended in the treatment venous insufficiency. Degressive compressive stockings have been used for many decades and are characterized by a high pressure applied at the ankle and a decreasing pressure from the ankle to the knee. Progressive compressive stockings were developed to have a maximal pressure at the calf. This concept is based on the calf pump role in the venous return. Patients with PAD (Peripheral Arterial Disease) often suffer from venous insufficiency. But elastic compression stockings are strictly contraindicated for patients with PAD because highest pressures on ankle could slow down the superficial microcirculation.

On patients with PAD and venous insufficiency, the progressive compressive stockings could be well indicated. Strongest pressure at the calf should increase the pump effect and the muscle mechanical efficiency during the walk without deleterious effect.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient suffering from a PAD (systolic pressure index ≥ 0,60 and ≤ 0,75) and having moderate venous insufficiency or classified as C1s to C4 using the CEAP classification
• Age over 18 years
• French health insurance
• Signed informed consent

Exclusion criteria

• Hypertension not controlled or hypertensive crisis (risk of non reproducibility of SPI and TBI)
• Diabetes
• Mediacalcosis (SPI not computable)
• Inflammatory arterial diseases of the lower limb
• Permanent edema, lipedema and lymphedema
• Wound and fragile skin
• Phlegmatia coerulea dolens
• Septic thrombophlebitis
• Severe coronary artery disease
• Oozing and infectious skin diseases, skin ulcers
• Known hypersensitivity to components of the study compressive stockings

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

contention socks

Experimental group

Description:

Patients wear evolutive contention socks during 15 days.

Treatment:

Device: contention socks