Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations

NCT01703182 | Terminated

• 1 other identifier: TCOM-2012
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation Wound

Keywords

transcutaneous oximetry; transcutaneous carbon dioxide; leg amputation; wound healing failure; amputation revision

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days post-surgery

Secondary Outcomes (4)

• 6-month all-cause mortality.

  6 months post-surgery

• Incidence of re-amputation from 30 days to 6 months post-amputation

  6 months post-surgery

• Use of prosthesis for mobilization within 6 months post-amputation

  6 months post-surgery

• Change in health-related quality of life from baseline at 6-months post-amputation

  6 months post-surgery

Study Arms (1)

leg amputation

Patients undergoing below-knee and above ankle amputation for vascular reasons will receive transcutaneous oximetry and transcutaneous carbon dioxide measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing below-knee and above-ankle amputations due to vascular complications

You may qualify if:

• Age ≥ 18 years
• Requires a lower limb amputation between the ankle and knee due to vascular complications
• Provides written informed consent

You may not qualify if:

• Requires a lower limb amputation for non-vascular reasons, including trauma and cancer
• Requires primary amputation below the level of the ankle or above the knee

Sponsors & Collaborators

• Population Health Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Study Officials

• Richard Whitlock, MD, FRCPC

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 10, 2012
• Study Start: April 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

CA (1)