Status:
COMPLETED
Effect of Topic Pirfenidone in Diabetic Ulcers
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Pirfenidone is a synthetic molecule, which acts as a potent modulator of the effect of various cytokines (TNF-α, transforming growth factor-β, platelet derived growth factor and vascular endothelial g...
Eligibility Criteria
Inclusion
- Men or women
- Type 1 or 2 diabetes
- Age ≥ 18 years
- Wagner 1 or 2 diabetic foot ulcer
- Diabetic ulcer for more than 8 weeks duration
- Willing to participate in the study with signed informed consent
Exclusion
- Ankle/brachial index \< 0.4 (critic ischemia)
- Use topical or systemic antibiotics
- Inability to attend to the weekly evaluations
- Inability to do daily ulcer cleansing
- Autoimmune diseases
- Active pharmacologic topical or systemic ulcer treatment
- Treatment with immunosuppressors such as steroids, radiotherapy, chemotherapy
- Pregnancy or lactation
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02222376
Start Date
October 1 2013
End Date
April 1 2015
Last Update
February 15 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, Mexico, 14000