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

Primary Purpose

Perfusion; Complications

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
HydroSun
Hilotherm
Sponsored by
Swiss Paraplegic Research, Nottwil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perfusion; Complications focused on measuring Complete paraplegia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Swiss Paraplegic Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HydroSun

Hilotherm

Arm Description

application of ultraviolet light for 30 minutes

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

Outcomes

Primary Outcome Measures

presence of burn injury
grade 1 (hyperemia, redness), grade 2 a/b (blisters) and grade 3 (necrosis)

Secondary Outcome Measures

blood perfusion
perfusion (PeriFlux System 5000) in perfusion units
skin surface temperature
measuring surface temperature with thermometer
skin redness
visual inspection

Full Information

First Posted
December 7, 2016
Last Updated
November 10, 2020
Sponsor
Swiss Paraplegic Research, Nottwil
Collaborators
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03001531
Brief Title
Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia
Acronym
DecuHeat
Official Title
Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Paraplegic Research, Nottwil
Collaborators
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perfusion; Complications
Keywords
Complete paraplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HydroSun
Arm Type
Active Comparator
Arm Description
application of ultraviolet light for 30 minutes
Arm Title
Hilotherm
Arm Type
Active Comparator
Arm Description
application of heat (maximum of 43°C) for 30 minutes
Intervention Type
Device
Intervention Name(s)
HydroSun
Intervention Description
a skin area of the lower limb will be treated three times with ultraviolet light emitted by a halogen lamp
Intervention Type
Device
Intervention Name(s)
Hilotherm
Intervention Description
a skin area of the lower limb will be treated three times with heat applied by a sleeve
Primary Outcome Measure Information:
Title
presence of burn injury
Description
grade 1 (hyperemia, redness), grade 2 a/b (blisters) and grade 3 (necrosis)
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
blood perfusion
Description
perfusion (PeriFlux System 5000) in perfusion units
Time Frame
before and 1min after the application of light or heat
Title
skin surface temperature
Description
measuring surface temperature with thermometer
Time Frame
before and 1min after the application of light or heat
Title
skin redness
Description
visual inspection
Time Frame
before and 1min after the application of light or heat

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Swiss Paraplegic Centre
City
Nottwil
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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