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

NCT ID: NCT02431819

Last Updated: 2016-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-11-30

Brief Summary

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.

Conditions

Peripheral Arterial Disease; Venous Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

contention socks

Patients wear evolutive contention socks during 15 days.

Group Type: EXPERIMENTAL

contention socks

Intervention Type: DEVICE

Patients wear contention socks during 15 days.

Interventions

contention socks

Patients wear contention socks during 15 days.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick MISMETTI, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Serge COUZAN, MD

Role: STUDY_DIRECTOR

Clinique Mutualiste Chirurgicale

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Clinique Mutualiste Chrirugicale

Saint-Etienne, , France

Countries

France

Other Identifiers

1408064

Identifier Type: -

Identifier Source: org_study_id