Overview

This trial is active, not recruiting.

Condition angiogenesis
Treatments insulin, placebo
Phase phase 3
Sponsor Hospital Central "Dr. Ignacio Morones Prieto"
Collaborator Universidad Autonoma de San Luis Potosí
Start date October 2014
End date April 2015
Trial size 20 participants
Trial identifier NCT02396888, 71-13

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Experimental)
Half of the wound surface was treated daily with intermediate insulin. Allocation was randomized.
insulin
Half of the wound surface was treated daily with 10 units of intermediate insulin.
(Placebo Comparator)
Half of the wound surface was treated daily with normal saline. Allocation was randomized.
placebo Normal saline
Half of the wound surface was treated daily with 0.1 cc of normal saline.

Primary Outcomes

Measure
Number of blood vessels
time frame: 14 days

Secondary Outcomes

Measure
Hypoglycaemia
time frame: 14 days

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Nondiabetic patients with full-thickness acute wounds Exclusion Criteria: - Diabetic patients

Additional Information

Official title Effects of Local Insulin on Angiogenesis in Acute Wounds in Non-diabetic Patients
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Hospital Central "Dr. Ignacio Morones Prieto".