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
About this trial
This is an interventional treatment trial for Perfusion; Complications focused on measuring Complete paraplegia
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
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
NCT ID
NCT03001531
First Posted
December 7, 2016
Last Updated
November 10, 2020
Sponsor
Swiss Paraplegic Research, Nottwil
Collaborators
University Hospital, Basel, Switzerland
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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