Impact of diabetic foot shoes containing nanoparticles Silver in reduce of foot bacterial strains in diabetic patients

Evaluation of antibacterial effect of diabetic foot shoes containing Silver nanoparticles

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201103151414N22

Enrollment

Registered

2011-05-10

Start date

2011-04-04

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

diabetes. Non-insulin-dependent diabetes mellitus

Interventions

Intervention 1: Intervention: Diabetic foot shoes made of natural leather coated with nanosilver particles will be given to the intervention group. Leather was provided by Charm Sazi Mojtahedi Co. (T

Prevention

Control: Diabetic foot shoes made of natural leather coated without nanosilver particles will be given to the intervention group. Leather was provided by Charm Sazi Mojtahedi Co. (Tabriz Iran). Pati

Intervention: Diabetic foot shoes made of natural leather coated with nanosilver particles will be given to the intervention group. Leather was provided by Charm Sazi Mojtahedi Co. (Tabriz Iran). Si

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: • type 2 diabetic patients aged 30-60 years, employed in government or private offices; • 9 / 0 30; • FBS <180; • HbA1C <8% (Normal Range:4-6%); • BP <130/80 • Michigan Diabetes Neuropathy Score (MDNS): Mild-Moderator. Exclusion criteria: • Antibiotic consumtion during the two weeks before entering the study; • active diabetic foot ulcers; • history of diabetic foot ulcers, gangrene and amputation; • Smoking cigarettes and other illegal drugs; • Michigan Diabetes Neuropathy Score (MDNS): Severe; • use of vasodilator drugs; • use of Vasoconstrictor drugs

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Cahnge in the number of foot bacterial strains in diabetic patients. Timepoint: first visit, 1 day, 1 week and 1 month after wearing shoes. Method of measurement: Sampling from three special sites including between the thumb and the side, plantar aspect of first metatarsal head and heel and strains calculation by blood agar plates and For calculation purposes, plate count values = 300 CFU were accepted.	—

Measure

Time frame

Cahnge in the number of foot bacterial strains in diabetic patients. Timepoint: first visit, 1 day, 1 week and 1 month after wearing shoes. Method of measurement: Sampling from three special sites including between the thumb and the side, plantar aspect of first metatarsal head and heel and strains calculation by blood agar plates and For calculation purposes, plate count values = 300 CFU were accepted.

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Countries

Iran (Islamic Republic of)

Outcome results

None listed

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