Effect of Topic Pirfenidone in Diabetic Ulcers (PirDFI)

February 12, 2016 updated by: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 14000
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional treatment
Weekly ulcer debridement and daily cleansing
Procedure: Debridement
Weekly ulcer debridement
Experimental: Pirfenidone
Weekly ulcer debridement, daily cleansing, plus twice a day topical pirfenidone application
Procedure: Debridement
Weekly ulcer debridement
Drug: Pirfenidone
Twice a day topical application
Other Names:
  • Kitoscell Q

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ulcer size
Time Frame: 16 weeks
16 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Healed ulcers
Time Frame: 16 weeks
16 weeks
Adverse effects
Time Frame: 16 weeks
16 weeks
Healing time
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Principal Investigator: Francisco J Gomez-Perez, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 19, 2014

First Posted (Estimate)

August 21, 2014

Study Record Updates

Last Update Posted (Estimate)

February 15, 2016

Last Update Submitted That Met QC Criteria

February 12, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIA-1031-13/14-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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