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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo |
|
| enteric-coated bromelain | Active Comparator | Intervention : Bromelain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromelain | Dietary Supplement | Dietary Supplement: Bromelain 1000 mg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wound surface area | Dimensions (length and width) by Image J | At baseline and every 2 weeks until the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of pain | By Visual Analogue Scale (VAS) | At baseline and every 2 weeks until the end of treatment at 8 weeks |
| The amount of inflammation | Lab test parameters of ESR & CRP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Azita Hekmatdoost, MD, PhD | Contact | +989123065084 | a_hekmat2000@yahoo.com | |
| Amir Rezazadeh, PharmD, BCPS | Contact | +989127298761 | Rezazadeh.am@iums.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| Mobina Tajdari, PharmD Student | Principal Investigator | |
| Kamyab Andarzbakhsh, PharmD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iran | Tehran | Tehran Province | 19835 | Iran |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D001963 | Bromelains |
| ID | Term |
|---|---|
| D003546 | Cysteine Endopeptidases |
| D057056 | Cysteine Proteases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Placebo |
| Dietary Supplement |
Placebo (1000 mg/day) |
|
| At baseline and every 4 weeks until the end of treatment at 8 weeks |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010450 | Endopeptidases |