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

NCT02431819 | Completed DMC

• 1 other identifier: 1408064
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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

Keywords

Peripheral Arterial Disease; Progressive compressive stockings

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (1)

contention socks

EXPERIMENTAL

Patients wear evolutive contention socks during 15 days.

Device: contention socks

Interventions

contention socks DEVICE

Patients wear contention socks during 15 days.

contention socks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (2)

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

Clinique Mutualiste Chrirugicale

Saint-Etienne, 42013, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Venous Insufficiency

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Patrick MISMETTI, MD PhD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

• Serge COUZAN, MD

  Clinique Mutualiste Chirurgicale

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 1, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 10, 2016

Record last verified: 2016-03

Locations

FR (2)