Comparing the effects of Elaeagnus angustifolia extract gel with crocin-loaded nanohydroxyapatite versus standard care on diabetic foot ulcer healing.

Comparing the effects of Elaeagnus angustifolia extract gel with crocin-loaded nanohydroxyapatite versus standard care on diabetic foot ulcer healing.

A controlled clinical trial with parallel groups, phase 0, was conducted on 30 patients. The rand function of Excel software was used for randomization.

Patients meeting the inclusion criteria will participate in the study. At every visit, wounds will be washed with sterile saline, with debridement as needed. Afterward, a thin gel layer will be applied daily to the wound for 20 days. Patients will receive daily follow-ups until healing is complete, with wound photographs taken every 10 days. The study takes place at the wound clinic of Imam Reza Hospital in Birjand.

This study focuses on patients with diabetic foot ulcers in Wagner stages 1 and 2, without clinical signs of infection, with controlled blood sugar and A1C levels, and who provide consent to participate in the study process, evaluation, and follow-up. Patients are excluded if they have recently undergone radiation or chemotherapy, are suspected of malignancy or other ulcer causes, or are pregnant or breastfeeding.

Control group: This group consists of patients with diabetic foot ulcers in stages 1 and 2 according to the Wagner scale. In addition to controlling blood sugar, their wounds are washed and dressed. • Treatment group: In addition to washing and dressing the wounds, this group is advised to apply topically once a day an Elaeagnus angustifolia extract gel containing crocin-loaded nanohydroxyapatite to the wound for faster healing.

Wound healing rate; healing time; side effects; patient satisfaction; changes in wound size

In this research design, to randomize the selection of patients with diabetes, first, a list of eligible patients is prepared, which includes information such as age, sex, type of diabetes, and severity of ulcers. Then, using a randomization software or random number table, the patients are divided into two groups: the first group receives treatment with elderberry extract gel containing crocin-loaded nanohydroxyapatite, and the second group receives standard treatment.