Effects of Local Insulin on Varicose Ulcers for Wound Healing

• Status: Completed
• Trial end date: 2020-02-15
• Target enrollment: 0
• Participant gender: All

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 at an approx depth of 3-4 mm. Treatment with insulin is administered for 7 days. Biopsy specimens of the two sides are obtained on days 0 and 7. A thermographic photograph of the wound is taken at days 0 and 7. The number of blood vessels and fibroplasia is evaluated as the main outcome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Central "Dr. Ignacio Morones Prieto"
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Any gender

• Presence of varicose ulcer in lower extremities with a size greater than 25 cm2

• Absence of infection

Exclusion Criteria:

• Presence of diabetes or glycated hemoglobin >6.5%

• Comorbidities that affect wound healing

• Malnutrition

• Active smoking