The effect of topical insulin and liothyronine on the healing of foot ulcer in patients with type 2 diabetes

Comparison of the effect of topical liothyronine and insulin formulations in improving diabetic foot ulcers in patients with type 2 diabetes

Patients in 3 groups will receive liothyronine Topical cream 0.75%, or combination liothyronine 0.75% and 0.5 IU Ins Reg /100 g cold cream, placebo (Alpha cream)according to standard diabetic foot care by the balanced block randomization method will be divided (each group 26) and twice a day apply a topical cream for 12 weeks.

The study will be conducted at the Yazd Diabetes Center in three phases: screening phase (7 days before prescribing the drug in terms of entry criteria), treatment (day zero to 4 weeks), and follow-up phase (2 and 3 months)

Inclusion criteria Exclusion criteria : 1) Patients over 18 years of age with a history of type 2 diabetes and hemoglobin A1C less than 10% 2) Adequate literacy to fill the consent form, study comprehension 3)Diabetic foot ulcer Conditions for leaving the study: 1) Gangrene of the foot 2) Osteomyelitis 3) Severe sepsis 4) History of alcohol consumption or substance abuse 5) History of chronic diseases such as cancers or congestive heart failure, ESRD, liver failure 6) Concomitant use of drugs that can adversely affect the wound healing process: glucocorticoids, immunosuppressive drugs, cytotoxic drugs 7) Failure to sign a written consent 8) Pregnant and lactating women 9) Patients with a history of steroid, cytotoxic or immunosuppressive drugs 10) Patients taking oral atorvastatin

One group will receive liothyronine topical cream, the other group insulin regular and liothyronine combination topical cream, and the control group will receive topical alpha ointment.

Percentage of wound closure per week, time of re-epithelialization 50% and 100%

In this study, 78 patients are randomly allocated into three treatment groups (A, B, and C). Block randomization method will be used for random allocation. Twelve blocks of six are considered. The generated permutations include the letters A, B, and C, which are repeated twice (for example, ABCABC) in each permutation. These permutations are generated using Random allocation software version 1. For this purpose, the generated list by the software is from 1 to 78, which are arranged in 12 blocks of six in order. To run this software output, we give the first qualified person number 1 and the last person will receive number 78. To consider blinding in random allocation, the list is given to another person outside the study and using short message service (SMS) before assigning the type of treatment according to the number of eligible people is asked and thus people enter the study. In addition, in the software output, both numbers 1 to 78 and the permutations of the letters A, B, and C can be seen.

After the products have been prepared, the first Executor, the treating physician, and the researcher monitoring the condition of the wounds will not be aware of any of the groupings performed. In this way, after preparing the products, liothyronine cream (150 mg liothyronine powder in 100 gr cold cream) or liothyronine/insulin cream (0.5 ml regular insulin in 99 gr liothyronine cream), these prepared creams and alpha cream (routine care), which all look the same, are placed in similar boxes. Then we ask another person to identify them with the codes A or B or C.