The effect of ointment based on ostrich oil containing honey, beeswax and ethanolic extracts of propolis, senna angustifolia and nigella sativa on wound healing on diabetic foot ulcer

The effect of ointment based on ostrich oil containing honey, beeswax and ethanolic extracts of propolis, senna Angustifolia and Nigella sativa on wound healing on diabetic foot ulcer

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 and 3 per 120 patients. Excel software rand function was used for randomization.

Random sampling is convinient in patients referred to the Sedigheh Tahereh Hospital of Isfahan University of Medical Sciences who have diabetic ulcers.The study is double-blind. The number of participants is 120. The doctor and the participants do not know how to be in the groups. Every day, one gram of prepared ointment and one gram of Eucerine (placebo) is rubbed on the wounds of patients in the placebo and treatment group. It is worth noting that none of the common treatments are discontinued. The wound condition is checked every week by a specialist doctor. The wound area is measured with a caliper.

Inclusion criteria: Grade 0, 1 and 2 foot ulcers Controlled blood sugar Exclusion criteria: 1. Consumption of cigarettes and alcoholic beverages 2. Taking anticoagulants 3. Taking immunosuppressive drugs 4. Having hemophilia 5. Use of drugs effective in wound healing (phenytoin, glucocorticoids, anti-cancer drugs and NASIDs) 6. Acute lower extremity circulatory failure

In the treatment group, we use from new formulation ( an ointment based on ostrich oil containing beeswax, honey, propolis ) for treatment of diabetic ulcers. In control group, we use from Eucerin as placebo. the Eucerin has not any effect on wound healing process.

The main outcome is the area of ​​the wound and the depth of the wound, which is measured by a caliper.

Samples were randomly divided into two experimental groups a or b. To do this, cards of the same shape and size on which a or b is written are placed in a box and each sample is asked to randomly select a card. People who take card a are in the test group and people who take card b are in the placebo group.

The patient and the clinician do not know the type of ointment. Ointments are similar in color and smell.

Not all data will be available.

The clinical article will be awaited after the completion of the trial.

Researchers and research companies can access the data.

Data will be available in the case of a scientific or commercial contract.

Please connect via below email: a_zargar@med.mui.ac.ir

Upon request, the researcher submits the data up to one month after the request.