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Treating blood-less legs with infra-red radiation.

The effect of far-infrared emitting socks on claudicant patients - a randomized clinical trial - : infra-rad radiation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7nr6sy
Enrollment
Unknown
Registered
2016-09-22
Start date
2015-12-12
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermitent claudication I70.2: lower extremity arterial atherosclerosis

Interventions

Intervention-arm: 20 claudicant patients will be assigned to use a infrared-emmitting stripe on the affected calf, associated with the standard treatment: cilostazol, ASA and a walking program. This s
Radiation
G01.750.770
C14.907.137.126.669
I73.9

Sponsors

Universidade Regional do Noroeste do Estado do Rio Grande do Sul
Lead Sponsor
Universidade do Sul de Santa Catarina
Collaborator

Eligibility

Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients with calf intermittent claudication, between 18 and 90 years old, with clinical evident stenosis or occlusion of the external iliac artery or common or superficial femoral artery; ankle-brachial index at or less than 0,9.

Exclusion criteria

Exclusion criteria: Impossibility to deambulate freely; DVT active or in the past; cancer; diabetic neuropathy needing specific treatment; major amputation.

Design outcomes

Primary

MeasureTime frame
6-minute walk test, in meters walked and by a percentage of the previewed for each patient. This measurement will be made in a standard manner, comprising walks on plain floor, in a patient-defined speed, with possible stops and smooth support words. An increment of 20 meters of the basal walked distance will be considered significative.

Secondary

MeasureTime frame
Claudication questionnaire: will be used the WIQ (Walking Impairment Questionnaire), portuguese-adapted, comprising four domains: distance, velocity and stairs. Increments of 10% will be considered significants.;Ankle-brachial index: the ankle arterial pressure and brachial pressure will be measured. Increments of 10% will be considered significative.;Flow-mediated arterial dilatation: the brachial artery diameter will be measured before and after an ischemic stimulus with a cuff. Increase in 1,5 to 2% will be considered significant.;Quality of life questionnaire: will be used a portuguese-validated version, with it's four domains: physical, psychological, social and environment. Increments of 10% will be considered significants.

Countries

Brazil

Contacts

Public ContactFabio da Silva

Universidade Regional do Noroeste do Estado do Rio Grande do Sul

fabiogoulartdasilva@gmail.com+55(55)33320200

Outcome results

None listed

Source: REBEC (via WHO ICTRP)