The Effects of Bromelain Supplement in Patients with Diabetic Foot Ulcers

NCT06786403 — Phase 3, Not yet recruiting, 70 participants, Dr Azita Hekmatdoost

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT06786403
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	70 (Estimated)
Sponsor	Dr Azita Hekmatdoost (Other)
Conditions	Diabetic Foot Ulcer (DFU)
Interventions	Bromelain, Placebo (Dietary supplement)
Dates	start 2025-03-01 (estimated), primary completion 2025-08-01 (estimated), completion 2025-10-01 (estimated), first posted 2025-01-22, last updated 2025-01-22
Locations	1 site in Iran

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
placebo	Placebo comparator	Dietary Supplement: Placebo	placebo
enteric-coated bromelain	Active comparator	Dietary Supplement: Bromelain	Intervention : Bromelain

Bromelain (Dietary supplement): Dietary Supplement: Bromelain 1000 mg/day
Placebo (Dietary supplement): Placebo (1000 mg/day)

+Outcome measures

Primary outcomes

Wound surface area [At baseline and every 2 weeks until the end of treatment at 8 weeks]: Dimensions (length and width) by Image J

Secondary outcomes

The amount of pain [At baseline and every 2 weeks until the end of treatment at 8 weeks]: By Visual Analogue Scale (VAS)
The amount of inflammation [At baseline and every 4 weeks until the end of treatment at 8 weeks]: Lab test parameters of ESR \& CRP

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Iran	Tehran, Tehran Province	Iran

+Investigators

Mobina Tajdari, PharmD Student, Principal investigator
Kamyab Andarzbakhsh, PharmD, Principal investigator

My Notes

Public

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