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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03001531
Acronym
DecuHeat
Enrollment
15
Registered
2016-12-23
Start date
2016-09-30
Completion date
2017-08-31
Last updated
2020-11-12

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

Conditions

Perfusion; Complications

Keywords

Complete paraplegia

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.

Interventions

DEVICEHydroSun

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

DEVICEHilotherm

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

Sponsors

University Hospital, Basel, Switzerland
CollaboratorOTHER
Swiss Paraplegic Research, Nottwil
Lead SponsorNETWORK

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
presence of burn injuryup to 24 hoursgrade 1 (hyperemia, redness), grade 2 a/b (blisters) and grade 3 (necrosis)

Secondary

MeasureTime frameDescription
blood perfusionbefore and 1min after the application of light or heatperfusion (PeriFlux System 5000) in perfusion units
skin surface temperaturebefore and 1min after the application of light or heatmeasuring surface temperature with thermometer
skin rednessbefore and 1min after the application of light or heatvisual inspection

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026