Evaluation of the effectiveness of topical and systemic treatments alone and in combination in the treatment of mild diabetic foot ulcers.

Evaluation of the effectiveness of topical disinfectants and antibiotics, alone and in combination with systemic antibiotics, in the treatment of mild diabetic foot wound infections: a single-center randomized clinical trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230629058615N12

Enrollment

132

Registered

2026-01-12

Start date

2025-12-03

Completion date

Unknown

Last updated

2026-06-01

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 circulatory complications

Interventions

Intervention 1: Intervention group1: Recipients of the SilvoSept brand (ChitoTech company) topical spray. Participants were required to apply a silver-based topical antiseptic to the site once daily f

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: All patients with type II and type I diabetes with diabetic foot ulcers (Wagner Grade 1 and 2) Clinical signs of mild infection (such as redness, discharge, pain, warmth, and inflammation) Age range 18 to 70 years Signing consent form to participate in the study Ability to decide for entering the study and cooperate for up to six months

Exclusion criteria

Exclusion criteria: Patients with renal failure (Serum creatinine level greater than 2 mg/dL) History of drug allergy to mupirocin History of drug allergy to cephalexin History of gangrene, necrosis, or osteomyelitis Uncontrolled diabetes (Hemoglobin A1c greater than 8.5%) Inability of the patient to fully comply with the study protocol Concomitant use of other antibiotics outside the study protocol

Design outcomes

Primary

Measure	Time frame
Wound Size. Timepoint: Day before intervention, day 14 after intervention, day 28 after intervention, day 42 after intervention. Method of measurement: Wound size analysis using ImageJ software.	—

Secondary

Measure	Time frame
Erythrocyte Sedimentation Rate. Timepoint: Day before intervention, day 42 after intervention. Method of measurement: Lena automatic Analyzer.;Medication Adverse Effects. Timepoint: One day before the start of the intervention, week 2 after the start of the intervention, week 4 after the start of the intervention, week 6 after the start of the intervention. Method of measurement: Drug side effects registration form.;C-Reactive Protein level. Timepoint: Day before intervention, day 42 after intervention. Method of measurement: Cobas c 311 analyzer.;White Blood Cells Count. Timepoint: Day before intervention, day 42 after intervention. Method of measurement: Sysmex KX21 Hematology Analyzer.	—

Measure

Time frame

Erythrocyte Sedimentation Rate. Timepoint: Day before intervention, day 42 after intervention. Method of measurement: Lena automatic Analyzer.;Medication Adverse Effects. Timepoint: One day before the start of the intervention, week 2 after the start of the intervention, week 4 after the start of the intervention, week 6 after the start of the intervention. Method of measurement: Drug side effects registration form.;C-Reactive Protein level. Timepoint: Day before intervention, day 42 after intervention. Method of measurement: Cobas c 311 analyzer.;White Blood Cells Count. Timepoint: Day before intervention, day 42 after intervention. Method of measurement: Sysmex KX21 Hematology Analyzer.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Rezazadeh

Iran University of Medical Sciences

rezazadeh.am@iums.ac.ir+98 912 729 8761

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026