The effect of topical insulin and liothyronine on the healing of foot ulcer

Phase 3

Conditions: Diabetic foot ulcer.
Type 2 diabetes mellitus with foot ulcer
E11.621

Registration Number: IRCT20190810044500N20

Lead Sponsor: Yazd University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 78

Inclusion Criteria

Patients over the age of 18 with a history of type 2 diabetes and hemoglobin A1C less than 10%
Adequate literacy to fill the consent form, comprehension study
Diabetic foot ulcer

Exclusion Criteria

Gangrene of the foot
Osteomyelitis
Severe sepsis
History of alcohol consumption or substance abuse
History of chronic diseases such as cancers or congestive heart failure, ESRD, liver failure
Concomitant use of drugs that can adversely affect the wound healing process: glucocorticoids, immunosuppressive drugs, cytotoxic drugs
Failure to sign a written consent
Pregnant and lactating women
Patients taking atrovastatin
Patients with a history of steroid, cytotoxic or immunosuppressive drugs

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of wound closures 1 to 4 per week. Timepoint: Screening phase (7 days perior to drug administration in terms of entery criteria), treatment (day zero to 4 weeks), and follow-up phase (2 and 3 months). Method of measurement: REEDA score (3-0).;Re-epithelialization. Timepoint: Screening phase (7 days perior to drug administration in terms of entery criteria), treatment (day zero to 4 weeks), and follow-up phase (2 and 3 months). Method of measurement: REEDA score (3-0).

Secondary Outcome Measures

Name	Time	Method
The severity of the pain. Timepoint: Examination from 7 days before prescribing the drug in terms of entry criteria, treatment (day zero to 4 weeks), and phase follow-up (2 and 3 months). Method of measurement: Basal Visual analogue Scale (VAS) criterion.;Occurrence of side effects. Timepoint: At the end of the study. Method of measurement: Based on Morisky medication adherence scale.