The Effects of Bromelain Supplement in Patients with Diabetic Foot Ulcers

NCT ID: NCT06786403

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Foot Ulcer (DFU)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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placebo

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (1000 mg/day)

enteric-coated bromelain

Intervention : Bromelain

Group Type ACTIVE_COMPARATOR

Bromelain

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Bromelain 1000 mg/day

Interventions

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Bromelain

Dietary Supplement: Bromelain 1000 mg/day

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (1000 mg/day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Azita Hekmatdoost

OTHER

Sponsor Role lead

Responsible Party

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Dr Azita Hekmatdoost

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mobina Tajdari, PharmD Student

Role: PRINCIPAL_INVESTIGATOR

Kamyab Andarzbakhsh, PharmD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Iran

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Central Contacts

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Azita Hekmatdoost, MD, PhD

Role: CONTACT

+989123065084

Amir Rezazadeh, PharmD, BCPS

Role: CONTACT

+989127298761

Facility Contacts

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Azita Hekmatdoost, MD, PhD

Role: primary

+989123065084

Mobina Tajdari, PharmD student

Role: backup

+989100037364

Other Identifiers

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162948239

Identifier Type: -

Identifier Source: org_study_id

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