Effect of combined magnesium and vitamin E supplementation in treatment of diabetic foot ulcer

Clinical trial of the effect of combined magnesium and vitamin E supplementation compared with the placebo on metabolic profiles in patients with diabetic foot ulcer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017090533941N21

Enrollment

Registered

2017-11-16

Start date

2017-10-20

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 ulcer. Non-insulin-dependent diabetes mellitus and with peripheral circulatory complications

Interventions

Intervention 1: Intervention group: 250 mg magnesium (21st Century, Arizona, USA) and 400 IU vitamin E (Zahravi, Tabriz, Iran) daily for 12 weeks orally. Intervention 2: Control group: Placebo capsule

Eligibility

Sex/Gender

All

Age

40 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients with grade 3 diabetic foot ulcer Aged 40 to 85

Exclusion criteria

Exclusion criteria: Pregnant and breastfed patients Participants who consumed magnesium, vitamin E or other antioxidative supplements during past 3 months Taking anti-inflammatory agents Change in consuming medications throughout the study Patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma

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
Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;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. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;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.;Magnesium. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.	—

Measure

Time frame

Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;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. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;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.;Magnesium. 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_z@kaums.ac.ir+98 31 5546 3378

Outcome results

None listed

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