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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431819
• Other study ID #: 1408064
• Status: Completed
• Phase: N/A
• First received: April 28, 2015
• Last updated: March 9, 2016
• Start date: February 2015
• Est. completion date: November 2015

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Venous Insufficiency

Intervention

Device:
• contention socks
Patients wear contention socks during 15 days.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-etienne
France	Clinique Mutualiste Chrirugicale	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change of the walking distance on treadmill compared to the walking distance at inclusion		Day 15	No
Secondary	Peripheral artery disease symptoms: muscle pain after physical effort, aches, cooling sensation, and paresthesia.		Day 15	No
Secondary	Venous insufficiency symptoms		Day 15	No
Secondary	Leg heaviness and tiredness leg		Day 15	No
Secondary	Pain leg evaluated by visual analogic scale		Day 15	No
Secondary	Absence of trophic disorder (new wound or ulcer)		Day 15	No
Secondary	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	No