Recruiting soon

Bromelain Supplement for Diabetic Foot Ulcers

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What is being tested

Bromelain

+ Placebo

Dietary Supplement
Who is being recruted

Cardiovascular Diseases+10

+ Diabetes Mellitus

+ Diabetic Angiopathies

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: March 2025
See protocol details

Summary

Principal SponsorDr Azita Hekmatdoost
Study ContactAzita Hekmatdoost, MD, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on exploring whether a supplement containing enteric-coated bromelain, known as Anaheal 1200 GDU, can help in healing wounds, reducing pain, and decreasing inflammation in individuals over 18 years old who have diabetic foot ulcers. Diabetic foot ulcers are a common complication for people with diabetes, often leading to severe consequences if not managed effectively. By comparing the effects of bromelain to a placebo, this study aims to find better treatment options that could improve healing and comfort for those affected by this condition. Participants in the study will be divided into two groups. One group will receive standard wound care treatment along with the bromelain supplement, while the other group will receive the same standard treatment with a placebo. Researchers will assess the size of the wound, the level of pain, and inflammation markers such as ESR and CRP at the start of the study and every two weeks. This will help determine the effectiveness of the bromelain supplement in promoting healing and reducing symptoms. All participants will be informed about the study procedures through a detailed consent form before joining.

Official TitleInvestigating 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
NCT06786403
Principal SponsorDr Azita Hekmatdoost
Study ContactAzita Hekmatdoost, MD, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusDiabetic AngiopathiesDiabetic NeuropathiesEndocrine System DiseasesLeg UlcerSkin DiseasesSkin UlcerVascular DiseasesFoot UlcerSkin and Connective Tissue DiseasesDiabetic FootDiabetes Complications

Criteria

3 inclusion criteria required to participate
Patients over 18 years old

Patients diagnosed with diabetic foot ulcers of category 0, 1 and 2 according to the Wagner criteria

Patients aware of the study process for monitoring after filling out the informed consent form

8 exclusion criteria prevent from participating
People who are allergic to pineapple, celery, carrot and fennel

Pregnant and lactating women

Severe kidney failure (GFR<30)

Severe liver failure (Child Pugh B, C)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Intervention : Bromelain

Group II

Placebo
placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Iran

Tehran, IranOpen Iran in Google Maps
Recruiting soonOne Study Center
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