NCT04310280

Effects of Local Insulin on Varicose Ulcers for Wound Healing

Effects of Local Insulin on Wound Angiogenesis and Fibroplasia in Varicose Ulcers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Hospital Central "Dr. Ignacio Morones Prieto" · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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 present study. A split-mouth model is used. The ulcer is divided into two (sides A and B). The side in which treatment is applied is randomized. Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Both halves are covered with dressings and compression therapy is applied. 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, as control of the local temperature of the wound. This is to asses the process of healing and to correlate with our outcome measures. The number of blood vessels will be evaluated as the main outcome. Fibroplasia and thermal asymmetry between wound sides will be evaluated as secondary outcomes.

Conditions

• Chronic Venous Disease
• Varicose Ulcer
• Wound Healing
• Insulin
• Angiogenesis

Interventions

Type	Name	Description
DRUG	Insulin Glargine	Half of the wound surface is injected daily with topical glargine insulin
DRUG	Saline	Half of the wound surface is injected daily with topical saline solution

Timeline

• Start date: 2019-06-01
• Primary completion: 2019-12-31
• Completion: 2020-02-15
• First posted: 2020-03-17
• Last updated: 2020-03-17

Locations

1 site across 1 country: Mexico