Effects of Local Insulin on Wound Angiogenesis

Hospital Central "Dr. Ignacio Morones Prieto"

Status and phase: Unknown; Phase 3

Conditions: Angiogenesis

Treatments: Drug: Insulin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02396888

71-13

Details and patient eligibility

About

Randomized, split plot, double-blind, placebo controlled trial. Half of the wounds surface was applied daily with insulin and the other half with saline solution as placebo. Biopsy specimens of the two sides were obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.

Full description

Randomized, split plot, double-blind, placebo controlled trial. Non-diabetic patients with full-thickness wounds will be treated in the following manner: in half of the surface insulin will be applied in a daily basis, on the other half, saline solution will be used as placebo. Biopsy specimens of both sides will be obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Nondiabetic patients with full-thickness acute wounds

Exclusion criteria

• Diabetic patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Insulin

Experimental group

Description:

Half of the wound surface was treated daily with intermediate insulin. Allocation was randomized.

Treatment:

Drug: Insulin

Placebo

Placebo Comparator group

Description:

Half of the wound surface was treated daily with normal saline. Allocation was randomized.

Treatment:

Drug: Placebo