Peripheral Arterial Disease, Venous Insufficiency
Conditions
Keywords
Peripheral Arterial Disease, Progressive compressive stockings
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.
Interventions
DEVICEcontention socks
Patients wear contention socks during 15 days.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the absence of worsening of PAD after 15 days of progressive compressive stockings ware | Day 15 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| 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 | Day 15 | 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. |
| Venous insufficiency symptoms | Day 15 | — |
Countries
France
Outcome results
None listed