drugset / Trial / NCT04310280

Effects of Local Insulin on Varicose Ulcers for Wound Healing

NCT04310280

Phase 3 Completed 13 enrolled Hospital Central "Dr. Ignacio Morones Prieto"
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2019-06-01
Primary completion
2019-12-31
Completion
2020-02-15

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic 10 iu Subcutaneous