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Completed

NCT Number: NCT02431819

Evaluation of the Safety of Compressive Socks to Treat 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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases Venous Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne, Saint-Etienne, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

contention socks

Device

Patients wear contention socks during 15 days.

Primary outcomes

  1. the absence of worsening of PAD after 15 days of progressive compressive stockings ware

    Time frame: 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 outcomes

  1. 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,

    Time frame: Day 15

  2. 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,

    Time frame: Day 15

  3. 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.

    Time frame: Day 15

  4. Change of the walking distance on treadmill compared to the walking distance at inclusion

    Time frame: Day 15

  5. Peripheral artery disease symptoms: muscle pain after physical effort, aches, cooling sensation, and paresthesia.

    Time frame: Day 15

  6. Venous insufficiency symptoms

    Time frame: Day 15

  7. Leg heaviness and tiredness leg

    Time frame: Day 15

  8. Pain leg evaluated by visual analogic scale

    Time frame: Day 15

  9. Absence of trophic disorder (new wound or ulcer)

    Time frame: Day 15

  10. Progressive compressive stockings compliance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 1, 2015
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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