preparation & evaluation of the effect of topical Metformin on the healing of diabetic foot in patients with type 2 diabetes

preparation & evaluation of topical Metformin 1% on the healing of diabetic foot in patients with type 2 diabetes: a randomized double-blind clinical trial study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190810044500N18

Enrollment

Registered

2021-08-16

Start date

2021-09-21

Completion date

Unknown

Last updated

2021-08-30

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

Conditions

Diabetic foot ulcer. Type 2 diabetes mellitus with foot ulcer

Interventions

Intervention 1: Intervention group: Patients use the topical metformin 1% cream twice a day for 12 weeks. Metformin powder will be purchased from Sigma and 1% metformin cream will be made in the pharm

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age more than 18 years old History of type 2 diabetes Hemoglobin A1C less than 10% Adequate literacy to fill out a consent form

Exclusion criteria

Exclusion criteria: Gangren Foot Osteomyelitis Severe sepsis A history of alcohol or substance abuse History of chronic diseases such as cancer, congestive heart failure, ESRD, or liver failure Concomitant use of drugs that may have a negative impact on the wound healing process: Glucocorticoids, immunosuppressive drugs, cytotoxic drugs Pregnancy Lactation Patients taking oral statins

Design outcomes

Primary

Measure	Time frame
The duration of the overall recovery period is up to 3 months. Timepoint: monthly. Method of measurement: REEDA score (3-0).;Inflation. Timepoint: weekly for 3 months. Method of measurement: REEDA score (3-0).;Redness. Timepoint: weekly for 3 months. Method of measurement: REEDA score (3-0).;Decreased secretions. Timepoint: Weekly for 3 months. Method of measurement: REEDA score (3-0).	—

Secondary

Measure	Time frame
The severity of the pain. Timepoint: 7 days before prescribing the drug, 0 to 4 weeks from the time of prescription and follow-up up to 2 months. Method of measurement: Based on Visual analogue scale (VAS) criterion.;Recovery percentage. Timepoint: 7 days before prescribing the drug, 0 to 4 weeks from the time of prescription and follow-up up to 2 months. Method of measurement: Based on Visual analogue scale (VAS) criterion.;Occurrence of side effects. Timepoint: At the end of the study. Method of measurement: The Morisky Medication Adherence Scale.;Quality of Life. Timepoint: At the end of the study. Method of measurement: Based on the EORTC QLQ-C30 questionnaire (version 3).	—

Measure

Time frame

The severity of the pain. Timepoint: 7 days before prescribing the drug, 0 to 4 weeks from the time of prescription and follow-up up to 2 months. Method of measurement: Based on Visual analogue scale (VAS) criterion.;Recovery percentage. Timepoint: 7 days before prescribing the drug, 0 to 4 weeks from the time of prescription and follow-up up to 2 months. Method of measurement: Based on Visual analogue scale (VAS) criterion.;Occurrence of side effects. Timepoint: At the end of the study. Method of measurement: The Morisky Medication Adherence Scale.;Quality of Life. Timepoint: At the end of the study. Method of measurement: Based on the EORTC QLQ-C30 questionnaire (version 3).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Saghafi

Yazd University of Medical Sciences

F.saghafi@ssu.ac.ir+98 35 3820 3419

Outcome results

None listed

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