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

Primary Purpose

Peripheral Arterial Disease, Venous Insufficiency

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
contention socks
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, Progressive compressive stockings

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Saint-Etienne
  • Clinique Mutualiste Chrirugicale

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

contention socks

Arm Description

Patients wear evolutive contention socks during 15 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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,
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,
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.
Change of the walking distance on treadmill compared to the walking distance at inclusion
Peripheral artery disease symptoms: muscle pain after physical effort, aches, cooling sensation, and paresthesia.
Venous insufficiency symptoms
Leg heaviness and tiredness leg
Pain leg evaluated by visual analogic scale
Absence of trophic disorder (new wound or ulcer)
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.

Full Information

First Posted
April 28, 2015
Last Updated
March 9, 2016
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02431819
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Venous Insufficiency
Keywords
Peripheral Arterial Disease, Progressive compressive stockings

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
contention socks
Arm Type
Experimental
Arm Description
Patients wear evolutive contention socks during 15 days.
Intervention Type
Device
Intervention Name(s)
contention socks
Intervention Description
Patients wear contention socks during 15 days.
Primary Outcome Measure Information:
Title
the absence of worsening of PAD after 15 days of progressive compressive stockings ware
Description
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.
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Change of the walking distance on treadmill compared to the walking distance at inclusion
Time Frame
Day 15
Title
Peripheral artery disease symptoms: muscle pain after physical effort, aches, cooling sensation, and paresthesia.
Time Frame
Day 15
Title
Venous insufficiency symptoms
Time Frame
Day 15
Title
Leg heaviness and tiredness leg
Time Frame
Day 15
Title
Pain leg evaluated by visual analogic scale
Time Frame
Day 15
Title
Absence of trophic disorder (new wound or ulcer)
Time Frame
Day 15
Title
Progressive compressive stockings compliance
Description
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.
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick MISMETTI, MD PhD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Serge COUZAN, MD
Organizational Affiliation
Clinique Mutualiste Chirurgicale
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-etienne
ZIP/Postal Code
42000
Country
France
Facility Name
Clinique Mutualiste Chrirugicale
City
Saint-etienne
ZIP/Postal Code
42013
Country
France

12. IPD Sharing Statement

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

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