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

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.

Study Overview

• Status: Terminated
• Conditions: 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 Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing below-knee and above-ankle amputations due to vascular complications

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-month all-cause mortality.	6-month all-cause mortality	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	6 months post-surgery
Use of prosthesis for mobilization within 6 months post-amputation	Use of prosthesis for mobilization within 6 months post-amputation	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)	6 months post-surgery

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Richard Whitlock, MD, FRCPC, Population Health Research Institute

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: October 5, 2012
• First Submitted That Met QC Criteria: October 5, 2012
• First Posted (Estimate): October 10, 2012

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: transcutaneous carbon dioxide; transcutaneous oximetry; leg amputation; wound healing failure; amputation revision
• Other Study ID Numbers: TCOM-2012