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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?

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000156381
Enrollment
20
Registered
2008-04-02
Start date
2008-05-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 on the day that prosthetic casting occurs.

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026