Investigating the effectiveness of the supplement containing enteric-coated bromelain (Anaheal 1200 GDU) in healing wounds, pain, and inflammation in patients over 18 years old with diabetic foot ulcers compared to placebo

Investigating the effectiveness of the supplement containing bromelain (Anaheal 1200 GDU enteric coated) on wound healing, pain, and inflammation in patients with diabetic foot ulcers

Phase 3 clinical trial is conducted on 70 patients, with a control group, with parallel groups, double-blind.

This study will be conducted on people over 18 with diabetic foot ulcers who refer to the diabetic foot ulcer center of Shariati Hospital in Tehran. The first group will receive the standard treatment along with Anaheal GDU 1200 (equals to 500 mg bromelain) supplement which contains bromelain and the second group will receive the standard treatment and placebo which contains Avicel. The informed consent form prepared in advance will also be provided to the patients so that they are fully familiar with the study process.

Inclusion criteria: patients over 18 years old with diabetic foot ulcers of categories 0, 1 and 2 according to the Wagner criteria Exclusion criteria: patients with allergies to certain foods (pineapple, celery, carrots, fennel), pregnant and lactating women, severe kidney and liver disorders, hemophilia, taking anticoagulants, patients with irregular heartbeat, tachycardia, asthma and other allergies that could interfere with the study.

In the experimental group, 35 adults with diabetic foot ulcers will receive Anaheal 1200 GDU in addition to the standard treatment. In the control group, 35 adults with diabetic foot ulcers will receive placebo in addition to standard treatment.

Wound surface area, rate of pain, rate of inflammatory factors (ESR and CRP)

In this study, volunteers were individually assigned into two Groups (drug and placebo) using block randomization. It should be noted that 4 sized blocks are used in this method. Block randomization was done using the "https://www.sealedenvelope.com" website and the obtained specialized codes (including two English letters and one number) were assigned to each candidate in the order of entry.

Block randomization is performed by an independent individual who labels the drugs and placebos based on the generated codes. The physician and the study executor administer the drug/placebo to patients using the corresponding code, without knowing the type of treatment. Similarly, patients receive treatment based on the specified code and are unaware of their treatment type. It is worth mentioning that the statistician is aware of the group allocations and uses the information provided by the independent individual to categorize patients into two groups and perform the statistical tests.

The final results of scoring the condition of the wound surface area inflammation, pain, and related parameters

After publishing the related article in international journals

Researchers in the field of medicine and pharmacy

Development of science and expand evidence related to treatment in further research

Islamic Azad University, Tehran Medical Sciences Branch: Respected applicants can use the following method to receive their desired documents or data from Islamic Azad University, Tehran Medical Sciences Branch: Communication with the Research and Technology Unit: To receive information and documents related to research and clinical trials, applicants can refer to the Research and Technology Unit of the university. Postal Address: Administrative Building Address: Administrative Building of Tehran Islamic Azad University of Medical Sciences, Gol Yakh Street, Ayeneh Boulevard, Amir Pabarja Street, Qolhak , Dr. Shariati Street, Tehran, Iran. Contact Number: 26602642-3 Email: rezazadeh.am@iums.ac.ir Website: www.tms.iau.ir

Request Submission and Documentation/Data Retrieval Process from the Research and Technology Department: Request Submission: Applicants must submit their request in writing, including full details (type of documents or data, purpose of request, and related supplementary information) to the university's Research and Technology Department. Method of Submission: Requests can be delivered in person to the Research and Technology Department. Postal Address: Administrative Building Address: Administrative Building of Tehran Islamic Azad University of Medical Sciences, Gol Yakh Street, Ayeneh Boulevard, Amir Pabarja Street, Qolhak , Dr. Shariati Street, Tehran, Iran. Phone Number: 26602642-3.Request Review: After receiving the request, the Research and Technology Department staff will review it. This review includes assessing the content of the request and determining if additional information is needed. If further clarification or adjustments are required, the applicant will be contacted via email or phone. Document/Data Delivery: Once prepared, the requested documents or data will be delivered to the applicant either in person or electronically. Delivery Methods: Electronic: Sent via email. Final Delivery Timeframe: 1 to 2 business days after preparation.Follow-up and Communication: Applicants can contact the Research and Technology Department at any stage of the process to follow up on the status of their request. Phone Number: 26602642-3.stimated Overall Timeframe for Receiving Documents/Data: From the time the request is submitted until the final receipt of documents or data, the process typically takes between 15 and 20 business days."