An observational study in Amputation Wound, sponsored by Population Health Research Institute. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-23.
Sponsored by Population Health Research Institute · Observational
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.
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.
Population Health Research Institute is the lead sponsor of 114 studies on the registry; 27 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients undergoing below-knee and above-ankle amputations due to vascular complications
Exclusion Criteria:
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
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.
Time frame: 30 days post-surgery
6-month all-cause mortality.
6-month all-cause mortality
Time frame: 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
Time frame: 6 months post-surgery
Use of prosthesis for mobilization within 6 months post-amputation
Use of prosthesis for mobilization within 6 months post-amputation
Time frame: 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)
Time frame: 6 months post-surgery
This study is terminated, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Population Health Research Institute