The Effects of Bromelain Supplement 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

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06786403

Enrollment

Registered

2025-01-22

Start date

2025-03-31

Completion date

2025-10-31

Last updated

2025-01-22

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

Conditions

Diabetic Foot Ulcer (DFU)

Keywords

diabetic foot ulcer, bromelain

Brief summary

This study will be conducted on people over 18 with diabetic foot ulcers.. The first group will receive the standard treatment along with bromelain supplement and the second group will receive the standard treatment and placebo. The informed consent form prepared in advance will also be provided to the patients so that they are fully familiar with the study process. Wound surface area, rate of pain, rate of inflammatory factors (ESR and CRP) will be assessed at baseline and every two weeks.

Interventions

DIETARY_SUPPLEMENTBromelain

Dietary Supplement: Bromelain 1000 mg/day

DIETARY_SUPPLEMENTPlacebo

Placebo (1000 mg/day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

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 * Patients with asthma

Design outcomes

Primary

Measure	Time frame	Description
Wound surface area	At baseline and every 2 weeks until the end of treatment at 8 weeks	Dimensions (length and width) by Image J

Secondary

Measure	Time frame	Description
The amount of pain	At baseline and every 2 weeks until the end of treatment at 8 weeks	By Visual Analogue Scale (VAS)
The amount of inflammation	At baseline and every 4 weeks until the end of treatment at 8 weeks	Lab test parameters of ESR & CRP

Countries

Iran

Contacts

Primary ContactAzita Hekmatdoost, MD, PhD

a_hekmat2000@yahoo.com+989123065084

Backup ContactAmir Rezazadeh, PharmD, BCPS

Rezazadeh.am@iums.ac.ir+989127298761

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026