Overview

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