Effect of Topic Pirfenidone in Diabetic Ulcers

Diabetic Foot Ulcers Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02222376
• Other study ID #: DIA-1031-13/14-1
• Status: Completed
• Phase: Phase 3
• First received: August 19, 2014
• Last updated: February 12, 2016
• Start date: October 2013
• Est. completion date: April 2015

Study information

• Verified date: February 2016
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Drug:
• Pirfenidone
Twice a day topical application

Procedure:
• Debridement
Weekly ulcer debridement

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Healed ulcers		16 weeks	No
Other	Adverse effects		16 weeks	Yes
Other	Healing time		16 weeks	No
Primary	Ulcer size		16 weeks	No