The Effects of Bromelain Supplement in Patients with Diabetic Foot Ulcers

January 15, 2025 updated by: Dr Azita Hekmatdoost

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Dietary supplement: Placebo
Placebo (1000 mg/day)
Active Comparator: enteric-coated bromelain
Intervention : Bromelain
Dietary supplement: Bromelain
Dietary Supplement: Bromelain 1000 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline and every 2 weeks until the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
Lab test parameters of ESR & CRP
At baseline and every 4 weeks until the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Azita Hekmatdoost

Investigators

  • Principal Investigator: Mobina Tajdari, PharmD Student
  • Principal Investigator: Kamyab Andarzbakhsh, PharmD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 162948239

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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