NCT02222376

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

August 19, 2014

Last Update Submit

February 12, 2016

Conditions

Diabetic Foot Ulcers

Keywords

Diabetic ulcer, diabetic foot

Outcome Measures

Primary Outcomes (1)

  • Ulcer size

    16 weeks

Other Outcomes (3)

  • Healed ulcers

    16 weeks

  • Adverse effects

    16 weeks

  • Healing time

    16 weeks

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR

Weekly ulcer debridement and daily cleansing

Procedure: Debridement

Pirfenidone

EXPERIMENTAL

Weekly ulcer debridement, daily cleansing, plus twice a day topical pirfenidone application

Drug: PirfenidoneProcedure: Debridement

Interventions

PirfenidoneDRUG

Twice a day topical application

Also known as: Kitoscell Q
Pirfenidone
DebridementPROCEDURE

Weekly ulcer debridement

Conventional treatmentPirfenidone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14000, Mexico

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

pirfenidoneDebridement

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Francisco J Gomez-Perez, MD

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2014

First Posted

August 21, 2014

Study Start

October 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 15, 2016

Record last verified: 2016-02

Locations

ME(1)