Diabetic Foot Ulcer (DFU)Phase 3NCT06786403
The Effects of Bromelain Supplement in Patients with Diabetic Foot Ulcers
A Phase 3 study testing Bromelain in people with Diabetic Foot Ulcer (DFU), run by Dr Azita Hekmatdoost at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU)
- What is being tested?
- Bromelain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- Mar 2025to Oct 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site
Iran
Tehran, Tehran Province, 19835
Azita Hekmatdoost, MD, PhD, +989123065084, a_hekmat2000@yahoo.com
Mobina Tajdari, PharmD student, +989100037364, mobinatjdr@gmail.com
About this study
Official title: 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.
- Conditions
- Diabetic Foot Ulcer (DFU)
- Being tested
- Bromelain, Placebo
- Keywords
- diabetic foot ulcer, bromelain
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromelainDietary supplement
Dietary Supplement: Bromelain 1000 mg/day
PlaceboDietary supplement
Placebo (1000 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo Receives: Dietary Supplement: Placebo |
| enteric-coated bromelain | Active comparator | Intervention : Bromelain Receives: Dietary Supplement: Bromelain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound surface area
Dimensions (length and width) by Image J
Measured: At baseline and every 2 weeks until the end of treatment at 8 weeks
Secondary outcomes (2)
The amount of pain
By Visual Analogue Scale (VAS)
Measured: At baseline and every 2 weeks until the end of treatment at 8 weeks
The amount of inflammation
Lab test parameters of ESR \& CRP
Measured: At baseline and every 4 weeks until the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Azita Hekmatdoost
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
- Investigators
- Mobina Tajdari, PharmD Student, Principal investigatorKamyab Andarzbakhsh, PharmD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786403
- Sponsor's protocol ID
- 162948239
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06786403
- Acronym / sponsor ID
- 162948239
- Conditions
- Diabetic Foot Ulcer (DFU)
- Keywords
- diabetic foot ulcer, bromelain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dr Azita HekmatdoostUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: Placeboplacebo |
| enteric-coated bromelain | Active comparator | Dietary Supplement: BromelainIntervention : Bromelain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BromelainDietary Supplement: Bromelain 1000 mg/day | Dietary supplement | enteric-coated bromelain |
| PlaceboPlacebo (1000 mg/day) | Dietary supplement | placebo |
Primary outcome
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
2 secondary outcomes
The amount of pain
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Foot Ulcer (DFU)
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PAW-Hydrogel for Chronic Wound Healing
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Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Recruiting
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
Recruiting
Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Diabetic Foot Ulcer, Foot Ulcer Chronic
Active, not recruiting
Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers
Diabetic Foot Ulcer (DFU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mobina Tajdari, PharmD Student principal investigator
Kamyab Andarzbakhsh, PharmD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bromelain in people with Diabetic Foot Ulcer (DFU), run by Dr Azita Hekmatdoost at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Azita Hekmatdoost, MD, PhD (+989123065084, a_hekmat2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound surface area (time frame: At baseline and every 2 weeks until the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.