Not Yet RecruitingPhase 3ACTRN12608000156381

Arginine and wound healing in patients recovering from a lower limb amputation

The effectiveness of an Arginine-enriched diet in patients with a lower-limb amputation. Does it reduce healing time and faciliate earlier prosthetic fitting?


Sponsor

Flinders University

Enrollment

20 participants

Start Date

May 1, 2008

Study Type

Interventional

Conditions

Summary

Patients admitted to RGH for a lower-limb amputation 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 amputation wound to heal, and the time taken to have a prosthetic limb fitted. 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

Inclusion Criteria1

  • All patients admitted to the Vascular unit at the Repatriation General Hospital for a trans-tibial or trans-femoral amputation.

Exclusion Criteria1

  • Patients who have not had a rigid removable dressing fitted within 24 hours of surgery. Patients receiving palliative care and ICU 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

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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 on the day that prosthetic casting occurs.


Locations(1)

Australia

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ACTRN12608000156381