Effects of supplementation in the treatment of diabetic foot

Effects of zinc supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in patients with diabetic foot

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201506215623N46

Enrollment

Registered

2015-07-03

Start date

2015-06-02

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

Diabetic foot. With peripheral circulatory complications

Interventions

Intervention 1: Intervention group: Zinc capsule, 50 mg, daily for 12 weeks orally. Intervention 2: Control group: Placebo capsule, daily for 12 weeks orally.

Eligibility

Sex/Gender

All

Age

40 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients with diabetic foot according to Wagner criteria higher than 5 years of their disease; aged 40 to 85 years

Exclusion criteria

Exclusion criteria: The use of substitute treatments including hormone or vitamin or zinc supplements Patients with chronic kidney disease, liver, lung, chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies Patients with low immune system ability (autoimmune) Pregnant Lactating

Design outcomes

Primary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Healing of diabetic foot ulcer. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm).	—

Measure

Time frame

Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Healing of diabetic foot ulcer. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm).

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Secondary

Measure	Time frame
VLDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HbA1c. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Biochemical kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;LDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.	—

Measure

Time frame

VLDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HbA1c. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Biochemical kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;LDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026