Status:

COMPLETED

Effects of Local Insulin on Varicose Ulcers for Wound Healing

Lead Sponsor:

Hospital Central "Dr. Ignacio Morones Prieto"

Conditions:

Chronic Venous Disease

Varicose Ulcer

Eligibility:

All Genders

18-85 years

Phase:

PHASE3

Brief Summary

A randomized, split-plot, double-blind, placebo-controlled trial. The varicose ulcer is divided into two (side A and B). Half of the wound's surface is treated locally with insulin (Glargine) applied ...

Detailed Description

A randomized, split-plot, double-blind, placebo-controlled trial. Chronic Varicose Ulcers measuring more than 4 cm in any of its dimensions, and that comply with candidate criteria are included in the...

Eligibility Criteria

Inclusion

  • Any gender
  • Presence of varicose ulcer in lower extremities with a size greater than 25 cm2
  • Absence of infection

Exclusion

  • Presence of diabetes or glycated hemoglobin \>6.5%
  • Comorbidities that affect wound healing
  • Malnutrition
  • Active smoking

Key Trial Info

Start Date :

June 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 15 2020

Estimated Enrollment :

13 Patients enrolled

Trial Details

Trial ID

NCT04310280

Start Date

June 1 2019

End Date

February 15 2020

Last Update

March 17 2020

Active Locations (1)

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Mario Aurelio Martínez-Jiménez

San Luis Potosí City, San Luis Potosí, Mexico, 78220