The Effects of Bromelain Supplement in Patients with Diabetic Foot Ulcers

NCT06786403 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 162948239
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer (DFU)

Keywords

diabetic foot ulcer; bromelain

Outcome Measures

Primary Outcomes (1)

• Wound surface area

  Dimensions (length and width) by Image J

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

Secondary Outcomes (2)

• The amount of pain

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

• The amount of inflammation

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

Study Arms (2)

placebo

PLACEBO COMPARATOR

placebo

Dietary Supplement: Placebo

enteric-coated bromelain

ACTIVE COMPARATOR

Intervention : Bromelain

Dietary Supplement: Bromelain

Interventions

Bromelain DIETARY_SUPPLEMENT

Dietary Supplement: Bromelain 1000 mg/day

enteric-coated bromelain

Placebo DIETARY_SUPPLEMENT

Placebo (1000 mg/day)

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Azita Hekmatdoost: lead

Study Sites (1)

Iran

Tehran, Tehran Province, 19835, Iran

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Bromelains

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cysteine Endopeptidases; Cysteine Proteases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Endopeptidases

Study Officials

• Mobina Tajdari, PharmD Student

  PRINCIPAL INVESTIGATOR

• Kamyab Andarzbakhsh, PharmD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Azita Hekmatdoost, MD, PhD

CONTACT

+989123065084; a_hekmat2000@yahoo.com

Amir Rezazadeh, PharmD, BCPS

CONTACT

+989127298761; Rezazadeh.am@iums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 22, 2025
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

IR (1)