Amputation WoundTCOMNCT01703182
Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations
An observational study of Amputation Wound, run by Population Health Research Institute at 1 site in Canada.
Trial summary
TCOM is a multicentre prospective cohort study in patients undergoing lower limb amputations. Patients will provide oxygen and carbon dioxide measurements in the lower limb for 20 to 30 minutes before their surgery and will be followed up until 6 months after their surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation Wound
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Jun 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing below-knee and above-ankle amputations due to vascular complications
Who may be able to join
- Age ≥ 18 years
- Requires a lower limb amputation between the ankle and knee due to vascular complications
- Provides written informed consent
Who cannot join
- Requires a lower limb amputation for non-vascular reasons, including trauma and cancer
- Requires primary amputation below the level of the ankle or above the knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations - An Observational Study
TCOM is a multicentre prospective cohort study in patients undergoing lower limb amputations. Patients will provide oxygen and carbon dioxide measurements in the lower limb for 20 to 30 minutes before their surgery and will be followed up until 6 months after their surgery. The purpose of the TCOM study is to determine the ability of oxygen and carbon dioxide measurements in the legs of patients undergoing lower limb amputation to predict wound healing complications and to determine an optimum cutoff value for both oxygen and carbon dioxide levels beyond which healing complications are likely to occur and a closer amputation level is indicated.
Read the detailed description
Lower limb amputation is a serious and unfortunate outcome for many patients with vascular disease, especially those with diabetes. It results in significant decreases in all aspects of quality of life. The need for further surgery to revise the amputation to a more proximal level leads to increased potential for serious and life-threatening complications, as well as a decrease in patient morale. From surveys and background literature, it can be estimated that there are approximately 8600 vascular disease-related lower limb amputations in Canada each year. As the epidemic of diabetes continues to unfold and the mean age of the population increases, this number is expected to increase. The results of this study may significantly assist in the surgical and clinical care of this patient population by providing clinicians with a means to assess appropriate lower limb amputation levels.
Further, the modalities of transcutaneous measures may assist in guiding further intervention studies in higher risk patients to improve clinically important outcomes. This study will act in part as a feasibility trial for a randomized controlled trial assessing the efficacy of supplemental oxygen therapy, including hyperbaric oxygen therapy, as a therapeutic tool to increase rates of healing after lower limb amputation.
- Conditions
- Amputation Wound
- Keywords
- transcutaneous oximetry, transcutaneous carbon dioxide, leg amputation, wound healing failure, amputation revision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| leg amputation | Patients undergoing below-knee and above ankle amputation for vascular reasons will receive transcutaneous oximetry and transcutaneous carbon dioxide measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause 30-day mortality and healing failure of the surgical stump
Composite of all-cause 30-day mortality and healing failure of the surgical stump at 30 days postoperatively, defined as the need for amputation revision.
Measured: 30 days post-surgery
Secondary outcomes (4)
6-month all-cause mortality.
6-month all-cause mortality
Measured: 6 months post-surgery
Incidence of re-amputation from 30 days to 6 months post-amputation
Incidence of re-amputation from 30 days to 6 months post-amputation
Measured: 6 months post-surgery
Use of prosthesis for mobilization within 6 months post-amputation
Use of prosthesis for mobilization within 6 months post-amputation
Measured: 6 months post-surgery
Change in health-related quality of life from baseline at 6-months post-amputation
Change in health-related quality of life from baseline at 6-months post-amputation, based on the quality of life questionnaire (EuroQoL-5D)
Measured: 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startApr 2011
- Primary completionFeb 2014
- Study completionJun 2014
Why it stopped: Stopped due to feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation WoundStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Richard Whitlock, McMaster University
- Investigators
- Richard Whitlock, MD, FRCPC, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703182
- Sponsor's protocol ID
- TCOM-2012
- Acronym
- TCOM
- Status last verified
- Sep 2015
- First submitted
- 5 Oct 2012
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations - An Observational Study
- ClinicalTrials.gov ID
- NCT01703182
- Acronym / sponsor ID
- TCOM / TCOM-2012
- Conditions
- Amputation Wound
- Keywords
- transcutaneous oximetry, transcutaneous carbon dioxide, leg amputation, wound healing failure, amputation revision
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Stopped due to feasibility
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Oct 2012 (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.
TCOM is a multicentre prospective cohort study in patients undergoing lower limb amputations. Patients will provide oxygen and carbon dioxide measurements in the lower limb for 20 to 30 minutes before their surgery and will be followed up until 6 months after their surgery. The purpose of the TCOM study is to determine the ability of oxygen and carbon dioxide measurements in the legs of patients undergoing lower limb amputation to predict wound healing complications and to determine an optimum cutoff value for both oxygen and carbon dioxide levels beyond which healing complications are likely to occur and a closer amputation level is indicated.
Detailed description
Lower limb amputation is a serious and unfortunate outcome for many patients with vascular disease, especially those with diabetes. It results in significant decreases in all aspects of quality of life. The need for further surgery to revise the amputation to a more proximal level leads to increased potential for serious and life-threatening complications, as well as a decrease in patient morale. From surveys and background literature, it can be estimated that there are approximately 8600 vascular disease-related lower limb amputations in Canada each year. As the epidemic of diabetes continues to unfold and the mean age of the population increases, this number is expected to increase. The results of this study may significantly assist in the surgical and clinical care of this patient population by providing clinicians with a means to assess appropriate lower limb amputation levels.
Further, the modalities of transcutaneous measures may assist in guiding further intervention studies in higher risk patients to improve clinically important outcomes. This study will act in part as a feasibility trial for a randomized controlled trial assessing the efficacy of supplemental oxygen therapy, including hyperbaric oxygen therapy, as a therapeutic tool to increase rates of healing after lower limb amputation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| leg amputation | – | –Patients undergoing below-knee and above ankle amputation for vascular reasons will receive transcutaneous oximetry and transcutaneous carbon dioxide measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing below-knee and above-ankle amputations due to vascular complications
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Requires a lower limb amputation between the ankle and knee due to vascular complications
- Provides written informed consent
Key exclusion criteria (2 listed)
- Requires a lower limb amputation for non-vascular reasons, including trauma and cancer
- Requires primary amputation below the level of the ankle or above the knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of all-cause 30-day mortality and healing failure of the surgical stump
Time frame: 30 days post-surgery
Composite of all-cause 30-day mortality and healing failure of the surgical stump at 30 days postoperatively, defined as the need for amputation revision.
4 secondary outcomes
6-month all-cause mortality.
Time frame: 6 months post-surgery
Incidence of re-amputation from 30 days to 6 months post-amputation
Time frame: 6 months post-surgery
Use of prosthesis for mobilization within 6 months post-amputation
Time frame: 6 months post-surgery
Change in health-related quality of life from baseline at 6-months post-amputation
Time frame: 6 months post-surgery
Results and safety
The study was stopped early (reason given: Stopped due to feasibility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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.
Richard Whitlock, MD, FRCPC principal investigator
Population Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation Wound, run by Population Health Research Institute at 1 site in Canada.
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 3 inclusion and 2 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 23 Sep 2015. 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 Canada. 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: Stopped due to feasibility). 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?
Composite of all-cause 30-day mortality and healing failure of the surgical stump (time frame: 30 days post-surgery). 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 23 Sep 2015.