Investigating the effectiveness of the supplement containing enteric-coated bromelain (Anaheal 1200 GDU) in patients with diabetic foot ulcers

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230629058615N6

Enrollment

Registered

2024-10-31

Start date

2024-12-21

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic foot ulcer. Diabetes mellitus due to underlying condition with foot ulcer

Interventions

Intervention 1: Intervention group: It includes 35 patients over 18 years old with diabetic foot ulcers of categories 0, 1 and 2 according to Wagner criteria. After checking the study's inclusion and

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age 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

Exclusion criteria

Exclusion criteria: 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) Patients with hemophilia People taking anticoagulant drugs, anti-platelet and thrombolytic Patients with irregular heartbeat and tachycardia People with asthma

Design outcomes

Primary

Measure	Time frame
Dimensions (length and width) and wound surface area. Timepoint: At days 0, 14, 28, 42 and 56. Method of measurement: Using a Image J software.	—

Secondary

Measure	Time frame
The amount of pain. Timepoint: At days 0, 14, 28, 42 and 56. Method of measurement: Visual Analogue Scale.;Side effects of Anaheal 1200 GDU. Timepoint: At days 0, 14, 28, 42 and 56. Method of measurement: Ask the patient.;The amount of inflammation. Timepoint: At days 0, 28 and 56. Method of measurement: Lab test parameters of Erythrocyte Sedimentation Rate and C-reactive protein.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMobina Tajdari

Islamic Azad University

mobinatjdr@gmail.com+98 21 2264 0051

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026