Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations - An Observational Study (TCOM)
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 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|
- 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.
- 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)
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Patients undergoing below-knee and above ankle amputation for vascular reasons will receive transcutaneous oximetry and transcutaneous carbon dioxide measurement
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.
|Contact: Richard Whitlock, MD, FRCPC||905 527 4322 ext 40306||Richard.Whitlock@phri.ca|
|Contact: Jessica Vincent||905 527 4322 ext 40635||Jessica.Vincent@phri.ca|
|Hamilton General Hospital||Recruiting|
|Hamilton, Ontario, Canada, L8L 2X2|
|Contact: Richard Whitlock 905-527-4322 ext 40605 firstname.lastname@example.org|
|Principal Investigator:||Richard Whitlock, MD, FRCPC||Population Health Research Institute|