Clinical trial NCT02431819: Evaluation of the Safety of Compressive Socks to Treat Venous Insufficiency in Patients With Peripheral Arterial Disease
Official title: Single Center Prospective Study Evaluating the Safety of Progressive Compressive Stockings for the Treatment of Venous Insufficiency in Patients With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Venous Insufficiency
Keywords: Peripheral Arterial Disease
Progressive compressive stockings
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-05-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: the absence of worsening of PAD after 15 days of progressive compressive stockings ware
timeFrame: Day 15
Secondary outcomes:
measure: 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,
timeFrame: Day 15
measure: 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,
timeFrame: Day 15
measure: 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.
timeFrame: Day 15
measure: Change of the walking distance on treadmill compared to the walking distance at inclusion
timeFrame: Day 15
measure: Peripheral artery disease symptoms: muscle pain after physical effort, aches, cooling sensation, and paresthesia.
timeFrame: Day 15
measure: Venous insufficiency symptoms
timeFrame: Day 15
measure: Leg heaviness and tiredness leg
timeFrame: Day 15
measure: Pain leg evaluated by visual analogic scale
timeFrame: Day 15
measure: Absence of trophic disorder (new wound or ulcer)
timeFrame: Day 15
measure: Progressive compressive stockings compliance
timeFrame: Day 15
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
city: Saint-etienne
country: France
facility: Clinique Mutualiste Chrirugicale
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Patrick MISMETTI, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Mutualiste Chirurgicale
name: Serge COUZAN, MD
role: STUDY_DIRECTOR
References: