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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 February 2016 |
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Main ID: |
NCT02222376 |
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Date of registration:
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19/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Topic Pirfenidone in Diabetic Ulcers
PirDFI |
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Scientific title:
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Effect of Treatment of Diabetic Foot Ulcers With Topic 8% 1-phenyl-5-methyl-2-[1h]-Pyridone (Pirfenidone) Combined With Modified Disulfur Diallyl Oxide (Odd-m) in Gel. |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02222376 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Francisco J Gomez-Perez, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Men or women
2. Type 1 or 2 diabetes
3. Age = 18 years
4. Wagner 1 or 2 diabetic foot ulcer
5. Diabetic ulcer for more than 8 weeks duration
6. Willing to participate in the study with signed informed consent
Exclusion Criteria:
1. Ankle/brachial index < 0.4 (critic ischemia)
2. Use topical or systemic antibiotics
3. Inability to attend to the weekly evaluations
4. Inability to do daily ulcer cleansing
5. Autoimmune diseases
6. Active pharmacologic topical or systemic ulcer treatment
7. Treatment with immunosuppressors such as steroids, radiotherapy, chemotherapy
8. Pregnancy or lactation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetic Foot Ulcers
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Intervention(s)
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Procedure: Debridement
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Drug: Pirfenidone
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Primary Outcome(s)
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Ulcer size
[Time Frame: 16 weeks]
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Secondary ID(s)
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DIA-1031-13/14-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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