Comparison of healing rate of diabetic foot ulcer between two groups of dressing with ointment containing turmeric root extract and dressing with placebo in diabetic patients

Determining the healing rate of diabetic foot ulcer between two groups of dressing with ointment containing turmeric root extract and dressing with placebo in diabetic patients

A controlled, parallel-group, triple-blind, randomized, phase 2-3 clinical trial on 72 patients. Randomized Block Design method was used for randomization.

Samples will be searched from patients who were admitted to Isfahan medical centers with complaints of diabetic foot ulcers. Participants in the groups were recorded and recorded by an independent researcher in a sealed envelope. In the diabetic foot wound dressing group with placebo ointment the placebo ointment, which is filled with Eucerin, will be used on the wound and then bandaged. In the dressing group with curcumin ointment, the diabetic foot wound will be dressed once a day using an ointment containing turmeric extract. During the physical examination, the area and depth of the wound will be measured and recorded daily.

Patients with type 2 diabetes with grade 1, 2, or 3 diabetic foot ulcers with consent to participate in the study, who have not used other treatment methods, are not heavy smokers, and do not have morbid obesity or vascular insufficiency.

In the diabetic foot wound dressing group with placebo ointment, after usual washing with normal saline and routine treatment based on the TIME model, placebo ointment, which is completely similar to curcumin ointment in appearance, but filled with eucerin, will be used on the wound and then bandaged. . Eucerin's main topical product is a moisturizer. In the dressing group with curcumin ointment, the diabetic foot wound will be dressed once a day by a wound expert after washing with normal saline using an ointment containing turmeric root extract (so as to cover the wound).

Wound grading

This stage will be Randomized Block Design. At this stage, patients will be divided into 2 blocks (36 blocks of 2). Then they are sorted according to the national code (the larger national code of the first row of the block and the smaller national code of the second row of the block). After that, we refer to the table of random numbers for each block. If the selected number was from 0 to 4, the patient in the first row will join group A and the patient in the second row will join group B. If the selected number was from 5 to 9, the patient in the first row will join group B and the patient in the second row will join group A. After 36 patients in group A and 36 patients in group B are determined, the clinical pharmacologist, who is blinded to the selected patients, determines which group each of groups A and B will receive curcumin ointment or dressing. be with placebo ointment.

The placebo ointment looks exactly like the curcumin ointment, but it is filled with eucerin. Therefore, the researcher, the patient, and the data analyst are not aware of the type of ointment used, and only the data collector who is a trained clinical caregiver is aware of it.

Information is kept confidential.

Information about the main outcome can be shared

After publishing the results

Researchers working in academic and scientific institutions

Using data to complete studies

Dr. Gholamali Hoghooghi, Isfahan University of Medical Sciences

By examining the researcher's request and providing sufficient documentation of his research and the reason for using the data can be provided