Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations (TCOM)
|ClinicalTrials.gov Identifier: NCT01703182|
Recruitment Status : Terminated (Stopped due to feasibility)
First Posted : October 10, 2012
Last Update Posted : September 23, 2015
|Condition or disease|
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|
|Actual Enrollment :||41 participants|
|Official Title:||Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations - An Observational Study|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||June 2014|
Patients undergoing below-knee and above ankle amputation for vascular reasons will receive transcutaneous oximetry and transcutaneous carbon dioxide measurement
- 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.
- 6-month all-cause mortality. [ Time Frame: 6 months post-surgery ]6-month all-cause mortality
- 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
- 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
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703182
|Hamilton General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Richard Whitlock, MD, FRCPC||Population Health Research Institute|