completed

The objective of the TCOM study was to determine the ability of transcutaneous oximetry and transcutaneous carbon dioxide measurements in the legs of patients undergoing below-knee amputation to predict amputation wound healing failure and revision.

Primary endpoints:

  • To determine the ability of transcutaneous oximetry and transcutaneous CO2 measurements in the legs of patients undergoing below-knee amputation to predict amputation wound healing failure (defined as the need for amputation revision) and all-cause mortality at 30-days post-amputation.
  • To determine an optimum cut-off value for both transcutaneous oximetry and transcutaneous CO2 levels for predicting the occurrence of the first co-primary outcome (revision amputation to higher level or mortality).
Study Type

Observational

Study Design

Observational study

NO. of Countries

1

NO. of Sites

4

NO. of Participants

41

Study Period

2011 - 2014

Sponsor

PHRI

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