Investigating the effect of a topical gel containing Sumac extract and Cloxacillin on diabetic foot ulcer: a double-blind placebo-controlled trial

Determining the effect of gel application on wound area and dimensions, wound healing time, healing pain caused by diabetic wound , patients' quality of life Determination of safety and tolerability of gel used in patients

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2-3 on 66 patients

place of study : Diabetic foot ulcer clinic, University of Tehran Patients are included in the study based on inclusion and non-inclusion criteria and are assigned to the intervention or control group based on block randomization. Both types of gels have the same color, smell and appearance, and are poured into the same tubes. Each tube is assigned a code based on a table of random numbers and the researcher and the patient are not aware of it. The interventions will continue twice a day for 8 weeks. In case of infection in the wound during the study, infections will be treated.

inclusion criteria: Patients with type 1 or 2 Diabetes Age 30 years or older Grade 1 and 2 diabetic ulcers( Wagner classification system) Adherence to routine diabetes treatments ABI greater than 0.7 non-inclusion criteria: Pregnancy or Breastfeeding Presence of infection in the wound before admission Presence of neoplasia Use of immunosuppressive drugs

Intervention group and control group Both groups receive routine treatment including debridement, infection control and treatment (if the wound becomes infected), hospitalization (if necessary), and off-loading procedures. The intervention group will be given Sumac-Cloxacillin gel and the control group will be given placebo gel.

Wound area a: Calculated weekly by wound imaging and computer software. Presence or absence of infection in the wound: It is checked weekly by visual observation when visiting the patient's wound.

Multi-digit numerical codes (barcodes) are written on the packages that only the main person in charge of the research can open the codes if necessary and the type of medicine is specified. The codes are arranged in such a way that in the first ten codes, five packages contain one of the drugs and the other five packages contain the second drug. The same ratio is established in the second ten codes to the sixth ten codes. (Permuted Block Randomization) ABBAABABAB, BBAABABAAB, ABABBAABBA, AABABABABB, AAABABBBAB, BABABAABBA This type of design provides the conditions for intermediate tests, So that after the execution of each complete block, statistical tests can be performed, and if the result is reached and the difference between the two groups is significant, and the test power is maintained, the study can be stopped.

Sumac-cloxacillin gel and placebo gel both have the same color, smell and appearance and are poured into the same tubes. Each tube is assigned a code consisting of numbers and letters. These codes are distributed based on a table of random numbers between the drug and placebo groups and the researcher and the patient are not aware of it.

In the case of patient data, only a portion of the data, such as information about the main outcome or the like, can be shared. The documents to be published will be published in the article. The general consent form is available at the University Vice Chancellor for Research.

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