Arginine and wound healing in patients with critical limb ischaemia recovering from a bypass graft

Phase 3

Recruiting

• Conditions: ower-limb ischaemia; Lower-limb ischaemia; Surgery - Surgical techniques

• Registration Number: ACTRN12608000419369
• Lead Sponsor: Flinders University Faculty of Health Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

All patients with chronic critical lower-limb ischaemia admitted to the Vascular unit at the Repatriation General Hospital for a bypass graft procedure.

Exclusion Criteria

Patients receiving palliative care and ICU (intensive care unit) patients. Patients who are nil by mouth or who require enteral feeding or parenteral nutrition. Patients who are unable to fulfill the requirements of the study due to impaired cognition

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to wound healing; measured using a semi-quantitative wound assessment questionnaire developed by an experienced vascular clinical nurse[Day 0 (surgery) to day it is determined that wound is healed. Wound assessment will be conducted on a weekly basis throughout this period.];Length of stay[Day 0 (surgery) to hospital discharge]

Secondary Outcome Measures

Name	Time	Method
Quality of life measured by the AQoL (Assessment of Quality of Life) tool[Baseline (entrance to the study), 30 days, 3 months, and 6 months post-surgery];Change in nutritional health as determined by change in weight, Body Mass Index (BMI), corrected arm muscle area (CAMA) and nutritional intake[Baseline and at 3 day intervals until discharge from hospital]