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

Single Center Prospective Study Evaluating the Safety of Progressive Compressive Stockings for the Treatment of Venous Insufficiency in Patients With Peripheral Arterial Disease

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Venous Insufficiency
• Intervention / Treatment: Device: contention socks

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • Chu de Saint-Etienne
  • Saint-etienne, France, 42013
    • Clinique Mutualiste Chrirugicale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: contention socks; Patients wear evolutive contention socks during 15 days.	Device: contention socks; Patients wear contention socks during 15 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the absence of worsening of PAD after 15 days of progressive compressive stockings ware	The primary endpoint is a safety one: the absence of worsening of PAD after 15 days of progressive compressive stockings ware. A worsening is defined as: Worsening of the systolic ankle pressure index (SPI) defined by a relative reduction of the SPI higher than 15% compared to the index value at inclusion,; Worsening of the toe-brachial index (TBI) defined by a relative reduction of TBI higher than 15% compared to the index value at inclusion,; Relative reduction of the number of active and repetitive ankle extensions in upright position higher than 25% compared to the index value at inclusion. If at least one of these criteria is met, the PAD will be considered as worsening. If none of these criteria is met, the patient will be considered as no worsening.	Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The evolution of the systolic ankle pressure index (SPI) defined by a relative reduction of the SPI higher than 15% compared to the index value at inclusion,		Day 15
The evolution of the toe-brachial index (TBI) defined by a relative reduction of TBI higher than 15% compared to the index value at inclusion,		Day 15
The relative reduction of the number of active and repetitive ankle extensions in upright position higher than 25% compared to the index value at inclusion.		Day 15
Change of the walking distance on treadmill compared to the walking distance at inclusion		Day 15
Peripheral artery disease symptoms: muscle pain after physical effort, aches, cooling sensation, and paresthesia.		Day 15
Venous insufficiency symptoms		Day 15
Leg heaviness and tiredness leg		Day 15
Pain leg evaluated by visual analogic scale		Day 15
Absence of trophic disorder (new wound or ulcer)		Day 15
Progressive compressive stockings compliance	Progressive compressive stockings compliance will be evaluated by the number of patients stopping wearing the compression before day 15 and reasons for stopping. Patient feeling will also be recorded as free text.	Day 15

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Study Director: Serge COUZAN, MD, Clinique Mutualiste Chirurgicale

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: April 28, 2015
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (ESTIMATE): May 1, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): March 10, 2016
• Last Update Submitted That Met QC Criteria: March 9, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Peripheral Arterial Disease; Progressive compressive stockings
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: 1408064