Evaluation the effects of Atorvastatin on diabetic foot

Evaluation of Atorvastatin Gel on improvement of diabetic foot ulcer : A Prospective, double-Blind, Randomized,clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100107003014N24

Enrollment

Registered

2021-06-18

Start date

2019-11-11

Completion date

Unknown

Last updated

2021-06-21

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: Control group: Patients in this group (selected randomly and double blindly) will use a placebo gel. Gel formulation without any drugs (formulation without active ingredient, and conta

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Having Diabetic Wounds Grade 1 and 2 Based on Wagner Ratings Having a single sore in the legs or the ends of the fingers (and the sole of the leg or heel) Which has lasted at least 4 weeks

Exclusion criteria

Exclusion criteria: Having diseases that causing wound healing problems Like liver and kidney failure, heart failure, various cancers, vasculitis Taking alcohol and cigarettes or any drugs The presence of infectious ulcers requiring amputations.

Design outcomes

Primary

Measure	Time frame
Changing the degree of ulcer. Timepoint: Wound grade measurement at the beginning of the study (before intervention) And 7, 14 and 21 days After starting to use a drug gel. Method of measurement: Measuring the size of the wound, the amount of erythema, the amount of pain (VAS criteria) and Irritation.;Permanent pain. Timepoint: Measuring the amount of pain at the beginning of the study, the first week, the second, third ,and fourth weeks after the start of the study, is evaluated and recorded. Method of measurement: Visual Analogue Scale.;Wound Scope. Timepoint: Measuring the wound scope at the beginning of the study, the first week, the second, third ,and fourth weeks after the start of the study, is evaluated and recorded. Method of measurement: Observation with measuring instruments.	—

Measure

Time frame

Changing the degree of ulcer. Timepoint: Wound grade measurement at the beginning of the study (before intervention) And 7, 14 and 21 days After starting to use a drug gel. Method of measurement: Measuring the size of the wound, the amount of erythema, the amount of pain (VAS criteria) and Irritation.;Permanent pain. Timepoint: Measuring the amount of pain at the beginning of the study, the first week, the second, third ,and fourth weeks after the start of the study, is evaluated and recorded. Method of measurement: Visual Analogue Scale.;Wound Scope. Timepoint: Measuring the wound scope at the beginning of the study, the first week, the second, third ,and fourth weeks after the start of the study, is evaluated and recorded. Method of measurement: Observation with measuring instruments.

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Secondary

Measure	Time frame
Side effect during treatment. Timepoint: The type of side effect measured during treatment at the first, second, third and fourth week after the start of treatment. Method of measurement: observation and according to questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParham Salehi

Mazandaran University of Medical Sciences

parhamsalehi053@gmail.com+98 11 1354 3083

Outcome results

None listed

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