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

This study has been terminated.
(Stopped due to feasibility)
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Richard Whitlock, McMaster University
ClinicalTrials.gov Identifier:
NCT01703182
First received: October 5, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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
Amputation Wound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations - An Observational Study

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Composite of all-cause 30-day mortality and healing failure of the surgical stump [ Time Frame: 30 days post-surgery ] [ Designated as safety issue: No ]
    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:
  • 6-month all-cause mortality. [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    6-month all-cause mortality

  • Incidence of re-amputation from 30 days to 6 months post-amputation [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    Incidence of re-amputation from 30 days to 6 months post-amputation

  • Use of prosthesis for mobilization within 6 months post-amputation [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    Use of prosthesis for mobilization within 6 months post-amputation

  • Change in health-related quality of life from baseline at 6-months post-amputation [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    Change in health-related quality of life from baseline at 6-months post-amputation, based on the quality of life questionnaire (EuroQoL-5D)


Enrollment: 41
Study Start Date: April 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
leg amputation
Patients undergoing below-knee and above ankle amputation for vascular reasons will receive transcutaneous oximetry and transcutaneous carbon dioxide measurement

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Richard Whitlock, Assistant Professor, McMaster University
ClinicalTrials.gov Identifier: NCT01703182     History of Changes
Other Study ID Numbers: TCOM-2012
Study First Received: October 5, 2012
Last Updated: May 8, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on July 28, 2014