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NCT Number: NCT06786403

The Effects of Bromelain Supplement in Patients with Diabetic Foot Ulcers

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.

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Key information

Conditions

Diabetic Foot Ulcer (DFU) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bromelain

Dietary Supplement

Dietary Supplement: Bromelain 1000 mg/day

Placebo

Dietary Supplement

Placebo (1000 mg/day)

Primary outcomes

  1. Wound surface area

    Time frame: At baseline and every 2 weeks until the end of treatment at 8 weeks

    Dimensions (length and width) by Image J

Secondary outcomes

  1. The amount of pain

    Time frame: At baseline and every 2 weeks until the end of treatment at 8 weeks

    By Visual Analogue Scale (VAS)

  2. The amount of inflammation

    Time frame: At baseline and every 4 weeks until the end of treatment at 8 weeks

    Lab test parameters of ESR & CRP

Study contacts

Contact information is provided by the study sponsor or research team.

Amir Rezazadeh, PharmD, BCPS

CONTACT

[email protected]

+989127298761

Azita Hekmatdoost, MD, PhD

CONTACT

[email protected]

+989123065084

Sponsors and collaborators

Lead sponsor

Dr Azita Hekmatdoost

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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