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

Study Overview
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Brief Summary
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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.

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

Conditions
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Peripheral Arterial Disease, Venous Insufficiency

Intervention / Treatment
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* Device: contention socks


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: contention socks<br>Patients wear evolutive contention socks during 15 days. | Device: contention socks<br>* Patients wear contention socks during 15 days.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, Progressive compressive stockings