Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia

NCT ID: NCT03001531

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-08-31

Brief Summary

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Preconditioning of regional skin is known to reduce post surgery complications due to increased perfusion and better skin condition. The aim of this study is to prove that local heating through a standardized device in patients with spinal cord injury induces no burnings or other relevant side effects. The investigators expect an increased regional perfusion, temperature and redness.

Detailed Description

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Conditions

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Perfusion; Complications

Keywords

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Complete paraplegia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HydroSun

application of ultraviolet light for 30 minutes

Group Type ACTIVE_COMPARATOR

HydroSun

Intervention Type DEVICE

a skin area of the lower limb will be treated three times with ultraviolet light emitted by a halogen lamp

Hilotherm

application of heat (maximum of 43°C) for 30 minutes

Group Type ACTIVE_COMPARATOR

Hilotherm

Intervention Type DEVICE

a skin area of the lower limb will be treated three times with heat applied by a sleeve

Interventions

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HydroSun

a skin area of the lower limb will be treated three times with ultraviolet light emitted by a halogen lamp

Intervention Type DEVICE

Hilotherm

a skin area of the lower limb will be treated three times with heat applied by a sleeve

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* men and women
* aged from 18 to 65 years
* paraplegia Th2-Th12
* spinal cord injury had occurred \>12 weeks ago

Exclusion Criteria

* infections
* fever
* diabetes
* heart failure stadium III
* renal insufficiency stadium III.
* scars, wounds or other injuries in the area of treatment
* skin type V and VI on Fitzpatrick scale
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role collaborator

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Swiss Paraplegic Centre

Nottwil, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2014-05

Identifier Type: -

Identifier Source: org_study_id