Clinical trial NCT01703182: Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations
Official title: Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations - An Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Amputation Wound
Keywords: transcutaneous oximetry
transcutaneous carbon dioxide
leg amputation
wound healing failure
amputation revision
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-10-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing below-knee and above-ankle amputations due to vascular complications

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite of all-cause 30-day mortality and healing failure of the surgical stump
timeFrame: 30 days post-surgery
Secondary outcomes:
measure: 6-month all-cause mortality.
timeFrame: 6 months post-surgery
measure: Incidence of re-amputation from 30 days to 6 months post-amputation
timeFrame: 6 months post-surgery
measure: Use of prosthesis for mobilization within 6 months post-amputation
timeFrame: 6 months post-surgery
measure: Change in health-related quality of life from baseline at 6-months post-amputation
timeFrame: 6 months post-surgery
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Richard Whitlock, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: