Peripheral Arterial DiseaseNCT02431819
Evaluation of the Safety of Compressive Socks to Treat Venous Insufficiency in Patients With Peripheral Arterial Disease
A study testing contention socks in people with Peripheral Arterial Disease and Venous Insufficiency, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Venous Insufficiency
- What is being tested?
- contention socks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Saint-Etienne
Saint-Etienne, 42000
Clinique Mutualiste Chrirugicale
Saint-Etienne, 42013
About this study
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
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.
- Conditions
- Peripheral Arterial Disease, Venous Insufficiency
- Being tested
- contention socks
- Keywords
- Peripheral Arterial Disease, Progressive compressive stockings
- Medical subject headings
- Peripheral Arterial Disease, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contention socksDevice
Patients wear contention socks during 15 days.
| Study group | Role | What they receive |
|---|---|---|
| contention socks | Experimental | Patients wear evolutive contention socks during 15 days. Receives: Device: contention socks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 15
Secondary outcomes (10)
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,
Measured: 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,
Measured: 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.
Measured: Day 15
Change of the walking distance on treadmill compared to the walking distance at inclusion
Measured: Day 15
Peripheral artery disease symptoms: muscle pain after physical effort, aches, cooling sensation, and paresthesia.
Measured: Day 15
Venous insufficiency symptoms
Measured: Day 15
Leg heaviness and tiredness leg
Measured: Day 15
Pain leg evaluated by visual analogic scale
Measured: Day 15
Absence of trophic disorder (new wound or ulcer)
Measured: 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.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick MISMETTI, MD PhD, Principal investigator, CHU de SAINT-ETIENNESerge COUZAN, MD, Study director, Clinique Mutualiste Chirurgicale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431819
- Sponsor's protocol ID
- 1408064
- Status last verified
- Mar 2016
- First submitted
- 28 Apr 2015
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02431819
- Acronym / sponsor ID
- 1408064
- Conditions
- Peripheral Arterial Disease, Venous Insufficiency
- Keywords
- Peripheral Arterial Disease, Progressive compressive stockings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| contention socks | Experimental | Device: contention socksPatients wear evolutive contention socks during 15 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contention socksPatients wear contention socks during 15 days. | Device | contention socks |
Primary outcome
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.
10 secondary outcomes
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
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
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
Change of the walking distance on treadmill compared to the walking distance at inclusion
Time frame: Day 15
Peripheral artery disease symptoms: muscle pain after physical effort, aches, cooling sensation, and paresthesia.
Time frame: Day 15
Venous insufficiency symptoms
Time frame: Day 15
Leg heaviness and tiredness leg
Time frame: Day 15
Pain leg evaluated by visual analogic scale
Time frame: Day 15
Absence of trophic disorder (new wound or ulcer)
Time frame: Day 15
Progressive compressive stockings compliance
Time frame: Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick MISMETTI, MD PhD principal investigator
CHU de SAINT-ETIENNE
Serge COUZAN, MD study director
Clinique Mutualiste Chirurgicale
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contention socks in people with Peripheral Arterial Disease and Venous Insufficiency, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the absence of worsening of PAD after 15 days of progressive compressive stockings ware (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.