Effects of Local Insulin on Varicose Ulcers for Wound Healing

Hospital Central "Dr. Ignacio Morones Prieto"

Status and phase: Completed; Phase 3

Conditions: Chronic Venous Disease; Insulin; Varicose Ulcer; Wound Healing; Angiogenesis

Treatments: Drug: Saline; Drug: Insulin Glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT04310280

01-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 2 patient groups, including a placebo group

Topical insulin glargine

Experimental group

Description:

The wound surface is treated locally with glargine insulin injected sub-dermal in a daily matter for 7 days. Allocation is randomized.

Treatment:

Drug: Insulin Glargine

0.9% saline solution

Placebo Comparator group

Description:

The wound surface is treated with conventional wound care in a daily matter for 7 days. Allocation is randomized.

Treatment:

Drug: Saline