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Not yet recruiting NCT06786403

The Effects of Bromelain Supplement in Patients with Diabetic Foot Ulcers

Phase III Interventional Diabetic Foot Ulcer (DFU)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bromelain, Placebo.
Who it may be relevant to
Registry conditions: Diabetic Foot Ulcer (DFU). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iran
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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 supplement Bromelain
    Dietary Supplement: Bromelain 1000 mg/day
  • Dietary supplement Placebo
    Placebo (1000 mg/day)

Primary outcome measures

  • Wound surface area [Time frame: At baseline and every 2 weeks until the end of treatment at 8 weeks]
Secondary outcome measures (2)
  • The amount of pain [Time frame: At baseline and every 2 weeks until the end of treatment at 8 weeks]
  • The amount of inflammation [Time frame: At baseline and every 4 weeks until the end of treatment at 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Iran · 1 center
  • Iran — Tehran

Identifiers

NCT: NCT06786403 · 162948239

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗