Perfusion; ComplicationsDecuHeatNCT03001531
Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia
A study testing HydroSun and Hilotherm in people with Perfusion; Complications, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Perfusion; Complications
- What is being tested?
- HydroSun and Hilotherm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women
- aged from 18 to 65 years
- paraplegia Th2-Th12
- spinal cord injury had occurred >12 weeks ago
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Perfusion; Complications
- Being tested
- HydroSun, Hilotherm
- Keywords
- Complete paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroSunDevice
a skin area of the lower limb will be treated three times with ultraviolet light emitted by a halogen lamp
HilothermDevice
a skin area of the lower limb will be treated three times with heat applied by a sleeve
| Study group | Role | What they receive |
|---|---|---|
| HydroSun | Active comparator | application of ultraviolet light for 30 minutes Receives: Device: HydroSun |
| Hilotherm | Active comparator | application of heat (maximum of 43°C) for 30 minutes Receives: Device: Hilotherm |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of burn injury
grade 1 (hyperemia, redness), grade 2 a/b (blisters) and grade 3 (necrosis)
Measured: up to 24 hours
Secondary outcomes (3)
blood perfusion
perfusion (PeriFlux System 5000) in perfusion units
Measured: before and 1min after the application of light or heat
skin surface temperature
measuring surface temperature with thermometer
Measured: before and 1min after the application of light or heat
skin redness
visual inspection
Measured: before and 1min after the application of light or heat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Collaborators
- University Hospital, Basel, Switzerland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001531
- Sponsor's protocol ID
- 2014-05
- Acronym
- DecuHeat
- Status last verified
- Nov 2020
- First submitted
- 7 Dec 2016
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia
- ClinicalTrials.gov ID
- NCT03001531
- Acronym / sponsor ID
- DecuHeat / 2014-05
- Conditions
- Perfusion; Complications
- Keywords
- Complete paraplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- Sep 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HydroSun | Active comparator | Device: HydroSunapplication of ultraviolet light for 30 minutes |
| Hilotherm | Active comparator | Device: Hilothermapplication of heat (maximum of 43°C) for 30 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women
- aged from 18 to 65 years
- paraplegia Th2-Th12
- spinal cord injury had occurred >12 weeks ago
Key exclusion criteria (7 listed)
- infections
- fever
- diabetes
- heart failure stadium III
- renal insufficiency stadium III.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroSuna skin area of the lower limb will be treated three times with ultraviolet light emitted by a halogen lamp | Device | HydroSun |
| Hilotherma skin area of the lower limb will be treated three times with heat applied by a sleeve | Device | Hilotherm |
Primary outcome
presence of burn injury
Time frame: up to 24 hours
grade 1 (hyperemia, redness), grade 2 a/b (blisters) and grade 3 (necrosis)
3 secondary outcomes
blood perfusion
Time frame: before and 1min after the application of light or heat
skin surface temperature
Time frame: before and 1min after the application of light or heat
skin redness
Time frame: before and 1min after the application of light or heat
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HydroSun and Hilotherm in people with Perfusion; Complications, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of burn injury (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.