Effect of supplementation in treatment of patients with diabetic foot ulcer

Clinical trial of the effect of magnesium supplementation compared with the placebo on wound healing and metabolic profiles in patients with diabetic foot ulcer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201612225623N96

Enrollment

Registered

2017-01-02

Start date

2016-10-26

Completion date

Unknown

Last updated

2019-12-17

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: Magnesium capsule, 250 mg oxide magnesium (21 century, USA), once a day, for 12 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran),

Eligibility

Sex/Gender

All

Age

40 Years to 85 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Pregnant and breastfed patients Taking magnesium,multivitamin-mineral and antioxidant supplements and anti-inflammatory agents Patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma

Design outcomes

Primary

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

Measure

Time frame

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 (Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm)). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Ruler.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.

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Secondary

Measure	Time frame
Total antioxidant. 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.;Malondialdehyde. 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.;Nitric oxide. 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.;LDL cholesterol. 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.	—

Measure

Time frame

Total antioxidant. 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.;Malondialdehyde. 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.;Nitric oxide. 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.;LDL cholesterol. 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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5562 0608

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 10, 2026