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

Amputation Wound Clinical Trial

— TCOM  

Official title:

Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations - An Observational Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01703182
• Other study ID #: TCOM-2012
• Status: Terminated
• Phase: N/A
• First received: October 5, 2012
• Last updated: September 21, 2015
• Start date: April 2011
• Est. completion date: June 2014

Study information

• Verified date: September 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Amputation Wound

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	6-month all-cause mortality.	6-month all-cause mortality	6 months post-surgery	No
Secondary	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	No
Secondary	Use of prosthesis for mobilization within 6 months post-amputation	Use of prosthesis for mobilization within 6 months post-amputation	6 months post-surgery	No
Secondary	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	No