RecruitingPhase 3ACTRN12608000419369

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

The effectiveness of an Arginine-enriched diet in patients with critical limb ischaemia. Does it improve post-surgical outcomes?


Sponsor

Flinders University Faculty of Health Sciences

Enrollment

20 participants

Start Date

Aug 1, 2008

Study Type

Interventional

Conditions

Summary

Patients with critical lower-limb ischaemia admitted to RGH for a bypass graft will be invited to participate in a study investigating the effect of a diet that is enriched with arginine on the time taken for the surgical wound to heal. Participants will be allocated at random to receive either a standard hospital diet with 2 Arginine-enriched supplements or a standard hospital diet with 2 standard nutritional supplements, that are equal in energy, protein, vitamins and minerals. In addition to the time taken for the wound to heal, participants will also have their nutritional health measured via body weight, dietary intake and arm muscle stores. Quality of life will also be measured.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 100 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a diet supplemented with arginine — an amino acid that may support wound healing — can help patients with severe leg artery blockage (critical limb ischaemia) heal faster after bypass graft surgery. Participants will receive either regular hospital meals plus an arginine-enriched supplement or regular meals plus a standard nutritional supplement, to see which helps surgical wounds heal more quickly. You may be eligible if: - You are 18 years of age or older - You have been diagnosed with critical lower-limb ischaemia (severely reduced blood flow to the leg) - You are admitted to the vascular surgery unit for a bypass graft procedure - You are able to eat normally You may NOT be eligible if: - You are receiving palliative (end-of-life) care - You are in an intensive care unit - You are not eating by mouth, or require tube feeding or intravenous nutrition - You have impaired thinking or cognition that prevents you from fulfilling study requirements Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Standard hospital diet plus two tetrapaks of a commercially available Arginie-enriched oral nutrition supplement (9g Arginine/day). The intervention will commence on entry to the study and will cease

Standard hospital diet plus two tetrapaks of a commercially available Arginie-enriched oral nutrition supplement (9g Arginine/day). The intervention will commence on entry to the study and will cease 30 days after the time of the bypass graft


Locations(1)

Australia

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ACTRN12608000419369