Effect of Topic Pirfenidone in Diabetic Ulcers

NCT ID: NCT02222376

Last Updated: 2016-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-04-30

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.

Conditions

Diabetic Foot Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional treatment

Weekly ulcer debridement and daily cleansing

Group Type: ACTIVE_COMPARATOR

Debridement

Intervention Type: PROCEDURE

Weekly ulcer debridement

Pirfenidone

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

Group Type: EXPERIMENTAL

Pirfenidone

Intervention Type: DRUG

Twice a day topical application

Debridement

Intervention Type: PROCEDURE

Weekly ulcer debridement

Interventions

Pirfenidone

Twice a day topical application

Intervention Type: DRUG

Debridement

Weekly ulcer debridement

Intervention Type: PROCEDURE

Other Intervention Names

Kitoscell Q

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco J Gomez-Perez, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Locations

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

DIA-1031-13/14-1

Identifier Type: -

Identifier Source: org_study_id