Wound (Morphologic Abnormality)FROSTNCT01270477
Hyperbaric Oxygen Treatment as Adjuvant Treatment for Frost Injury
A study testing Hyperbaric oxygen treatment in people with Wound (Morphologic Abnormality), run by Oslo University Hospital at 1 site in Norway.
Trial summary
The aim of this study is to see weather hyperbaric oxygen treatment is beneficial as adjuvant treatment for frost damage. The investigators hope to include at least 20 patients in a randomized manner. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Wound (Morphologic Abnormality)
- What is being tested?
- Hyperbaric oxygen treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to 3 Mar 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70. Frost damage grade II-IV. Inclusion is needed within 48 hours from time of damage.
Who cannot join
- Pregnancy. Ventilator treatment. Problems with equalizing. High grade heart failure. Chronic obstructive lung disease of high grade. Treatment over 3 days after time of damage. Serious claustrophobia/psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Possible Improvement in Level of Sequela and Amputation/Amputation Level After Frost Injury by the Adjuvant Treatment of Hyperbaric Oxygen.
The aim of this study is to see weather hyperbaric oxygen treatment is beneficial as adjuvant treatment for frost damage.
The investigators hope to include at least 20 patients in a randomized manner. Half of the patients are randomized to hyperbaric oxygen, and half of the patients are randomized not to have hyperbaric oxygen treatment.
Under hypotheses: The number og surgeries is reduced by hyperbaric oxygen treatment as adjuvant treatment for frost damage. The functional level of the frost damaged patient is better after 6 and 12 months when also treated with hyperbaric oxygen treatment for frost damage.
- Conditions
- Wound (Morphologic Abnormality)
- Being tested
- Hyperbaric oxygen treatment
- Keywords
- Frost injury
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen treatmentOther
Also called Hyperoxic treatment, Pressure chamber treatment
Hyperbaric oxygen treatment for 2,5 hours at maximum 14 meters (standard table in Norway).
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen treatment | Experimental | Hyperbaric oxygen treatment in an hyperbaric oxygen treatment chamber on an recognized treatment table. Receives: Other: Hyperbaric oxygen treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperbaric oxygen treatment is favorable for tissue regeneration after frost injury.
Measured: From incusion of a patiant through a follow up after 1 year.
Secondary outcomes (1)
First: The number of surgeries is reduced with hyperbaric oxygen treatment.
Second: The level of amputation is further distal on the extremity with hyperbaric oxygen treatment.
Third: The level of function of the damaged bodypart is better after 6 and 12 months with hyperbaric treatment.
Measured: One year from the enrollment of a patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startJan 2011
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Why it stopped: Lack of People to follow up the study, work overload
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound (Morphologic Abnormality)Studies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helle Midtgaard, Oslo University Hospital
- Investigators
- Knut Ar Kirkeboen, MD Professor, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270477
- Sponsor's protocol ID
- FROST
- Acronym
- FROST
- Status last verified
- Apr 2011
- First submitted
- 3 Jan 2011
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Possible Improvement in Level of Sequela and Amputation/Amputation Level After Frost Injury by the Adjuvant Treatment of Hyperbaric Oxygen.
- ClinicalTrials.gov ID
- NCT01270477
- Acronym / sponsor ID
- FROST / FROST
- Conditions
- Wound (Morphologic Abnormality)
- Keywords
- Frost injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of People to follow up the study, work overload
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 5 Jan 2011 (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.
The aim of this study is to see weather hyperbaric oxygen treatment is beneficial as adjuvant treatment for frost damage.
The investigators hope to include at least 20 patients in a randomized manner. Half of the patients are randomized to hyperbaric oxygen, and half of the patients are randomized not to have hyperbaric oxygen treatment.
Under hypotheses: The number og surgeries is reduced by hyperbaric oxygen treatment as adjuvant treatment for frost damage. The functional level of the frost damaged patient is better after 6 and 12 months when also treated with hyperbaric oxygen treatment for frost damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen treatment | Experimental | Other: Hyperbaric oxygen treatmentHyperbaric oxygen treatment in an hyperbaric oxygen treatment chamber on an recognized treatment table. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-70. Frost damage grade II-IV. Inclusion is needed within 48 hours from time of damage.
Key exclusion criteria (1 listed)
- Pregnancy. Ventilator treatment. Problems with equalizing. High grade heart failure. Chronic obstructive lung disease of high grade. Treatment over 3 days after time of damage. Serious claustrophobia/psychiatric illness.
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 |
|---|---|---|
| Hyperbaric oxygen treatmentAlso: Hyperoxic treatment, Pressure chamber treatmentHyperbaric oxygen treatment for 2,5 hours at maximum 14 meters (standard table in Norway). | Other | Hyperbaric oxygen treatment |
Primary outcome
Hyperbaric oxygen treatment is favorable for tissue regeneration after frost injury.
Time frame: From incusion of a patiant through a follow up after 1 year.
1 secondary outcome
First: The number of surgeries is reduced with hyperbaric oxygen treatment.
Time frame: One year from the enrollment of a patient.
Results and safety
The study was stopped early (reason given: Lack of People to follow up the study, work overload). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
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.
Knut Ar Kirkeboen, MD Professor study director
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric oxygen treatment in people with Wound (Morphologic Abnormality), run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 4 Mar 2021. 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 Norway. 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 was stopped early (reason given: Lack of People to follow up the study, work overload). Results are not available in the source record.
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?
Hyperbaric oxygen treatment is favorable for tissue regeneration after frost injury. (time frame: From incusion of a patiant through a follow up after 1 year.). 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 4 Mar 2021.