The Effects of Bromelain Supplement in Patients with Diabetic Foot Ulcers

Dr Azita Hekmatdoost

Status and phase: Not yet enrolling; Phase 3

Conditions: Diabetic Foot Ulcer (DFU)

Treatments: Dietary Supplement: Bromelain; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06786403

162948239

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Dietary Supplement: Placebo

enteric-coated bromelain

Active Comparator group

Description:

Intervention : Bromelain

Treatment:

Dietary Supplement: Bromelain