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Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations (TCOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01703182
Recruitment Status : Terminated (Stopped due to feasibility)
First Posted : October 10, 2012
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease
Amputation Wound

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

Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations - An Observational Study
Study Start Date : April 2011
Primary Completion Date : February 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
leg amputation
Patients undergoing below-knee and above ankle amputation for vascular reasons will receive transcutaneous oximetry and transcutaneous carbon dioxide measurement


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 6-month all-cause mortality. [ Time Frame: 6 months post-surgery ]
    6-month all-cause mortality

  2. Incidence of re-amputation from 30 days to 6 months post-amputation [ Time Frame: 6 months post-surgery ]
    Incidence of re-amputation from 30 days to 6 months post-amputation

  3. Use of prosthesis for mobilization within 6 months post-amputation [ Time Frame: 6 months post-surgery ]
    Use of prosthesis for mobilization within 6 months post-amputation

  4. Change in health-related quality of life from baseline at 6-months post-amputation [ Time Frame: 6 months post-surgery ]
    Change in health-related quality of life from baseline at 6-months post-amputation, based on the quality of life questionnaire (EuroQoL-5D)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing below-knee and above-ankle amputations due to vascular complications
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Requires a lower limb amputation between the ankle and knee due to vascular complications
  3. Provides written informed consent

Exclusion Criteria:

  1. Requires a lower limb amputation for non-vascular reasons, including trauma and cancer
  2. Requires primary amputation below the level of the ankle or above the knee
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703182


Locations
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Richard Whitlock, MD, FRCPC Population Health Research Institute
More Information

Responsible Party: Richard Whitlock, Assistant Professor, McMaster University
ClinicalTrials.gov Identifier: NCT01703182     History of Changes
Other Study ID Numbers: TCOM-2012
First Posted: October 10, 2012    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Richard Whitlock, McMaster University:
transcutaneous oximetry
transcutaneous carbon dioxide
leg amputation
wound healing failure
amputation revision