The Effects of Bromelain Supplement in Patients with Diabetic Foot Ulcers

Last updated: January 15, 2025
Sponsor: Dr Azita Hekmatdoost
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes And Hypertension

Ulcers

Treatment

Bromelain

Placebo

Clinical Study ID

NCT06786403
162948239
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over 18 years old

  • Patients diagnosed with diabetic foot ulcers of category 0, 1 and 2 according to theWagner criteria

  • Patients aware of the study process for monitoring after filling out the informedconsent form

Exclusion

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 Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Bromelain
Phase: 3
Study Start date:
March 01, 2025
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Iran

    Tehran, 19835
    Iran, Islamic Republic of

    Site Not Available

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