The Effect of Nutritional Supplementation on the Healing of Diabetic Foot Ulcers

Not Applicable

Completed

• Conditions: Diabetic foot ulcers; Skin - Other skin conditions; Metabolic and Endocrine - Diabetes; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12612000036819
• Lead Sponsor: orthern Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-09
• Study Completion: 2024-08-24
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Study eligibility will include a confirmed diagnosis of Type 2 diabetes mellitus and a foot ulcer with an International Working Group of the Diabetic Foot (IWGDF) PEDIS classifications (as listed below) of at least 4 weeks duration.
1.Perfusion: Grades 1-3
2.Depth: Grades 1-3
3.Infection: Grades 1-3
4.Sensation: Grades 1 and 2

Exclusion Criteria

Patients with a Grade 4 infection rating according to the IWGDF PEDIS classification system will be excluded as systemic signs will usually require hospital admission. Patients with phenylketonuria, sepsis, chronic renal failure, malignancy, and chronic inflammatory bowel disease, will be excluded for health and safety reasons. Individuals receiving hydroxyurea or greater than 10 mg prednisolone or 1.5 mg dexamethasone per day will also be excluded as these drugs can impact on the rate of healing of diabetic foot ulcers. Individuals using insulin to manage their diabetes will also be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healing rate of the foot ulcer is the primary outcome measure of the study. Wounds will be measured using the IWGDF PEDIS system. The system classifies foot ulcers according to five categories: perfusion, extent/size, depth/tissue loss, infection and sensation and changes in these parameters over time will allow a quantitative measure of wound healing.[ Baseline, week 2 and 4]

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QoL) will be assessed using the Short Form-36 (SF-36) questionnaire[ Baseline and week 4];Nutrition assessment by subjective global assessment (SGA)[ Baseline];Information about dietary intake will be obtained using the multiple-pass 24-hour food recall method.[ Baseline, week 2 and 4]