Back to resultsEffect of Topic Pirfenidone in Diabetic Ulcers (PirDFI)
Primary Purpose
Diabetic Foot Ulcers
Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Pirfenidone
Debridement
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring Diabetic ulcer, diabetic foot
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional treatment
Pirfenidone
Arm Description
Weekly ulcer debridement and daily cleansing
Weekly ulcer debridement, daily cleansing, plus twice a day topical pirfenidone application
Outcomes
Primary Outcome Measures
Ulcer size
Secondary Outcome Measures
Full Information
NCT ID
NCT02222376
First Posted
August 19, 2014
Last Updated
February 12, 2016
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1. Study Identification
Unique Protocol Identification Number
NCT02222376
Brief Title
Effect of Topic Pirfenidone in Diabetic Ulcers
Acronym
PirDFI
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 growth factor, among others) that possesses anti-inflammatory and anti-fibrinolytic properties.
The aim of this study is to compare the effect of topic treatment with pirfenidone compared to conventional treatment in chronic diabetic foot ulcers.
The hypothesis is that treatment with topic pirfenidone in chronic diabetic foot ulcers (Wagner 1 to 2) reduces the ulcer size and shortens the healing time compared to conventional treatment. This is a randomized, controlled and crossover study. Patients will be randomly assigned to conventional treatment or topic pirfenidone for eight weeks. At the end of this period they will change groups. Each week ulcers will be for size, depth, length and evidence of infection. The ulcers will have proper debridement in the conventional treatment group and debridement plus topical pirfenidone application in the pirfenidone group. Subjects will be instructed to do daily ulcer cleansing and for those in the topical pirfenidone group, in addition to cleansing they will be instructed to apply the gel twice a day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
Keywords
Diabetic ulcer, diabetic foot
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
Weekly ulcer debridement and daily cleansing
Arm Title
Pirfenidone
Arm Type
Experimental
Arm Description
Weekly ulcer debridement, daily cleansing, plus twice a day topical pirfenidone application
Intervention Type
Drug
Intervention Name(s)
Pirfenidone
Other Intervention Name(s)
Kitoscell Q
Intervention Description
Twice a day topical application
Intervention Type
Procedure
Intervention Name(s)
Debridement
Intervention Description
Weekly ulcer debridement
Primary Outcome Measure Information:
Title
Ulcer size
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Healed ulcers
Time Frame
16 weeks
Title
Adverse effects
Time Frame
16 weeks
Title
Healing time
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco J Gomez-Perez, MD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14000
Country
Mexico
12. IPD Sharing Statement
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Effect of Topic Pirfenidone in Diabetic Ulcers
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