Effects of Local Insulin on Wound Angiogenesis

NCT ID: NCT02396888

Last Updated: 2015-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Angiogenesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Insulin

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

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

Half of the wound surface was treated daily with 10 units of intermediate insulin.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Half of the wound surface was treated daily with 0.1 cc of normal saline.

Interventions

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Insulin

Half of the wound surface was treated daily with 10 units of intermediate insulin.

Intervention Type DRUG

Placebo

Half of the wound surface was treated daily with 0.1 cc of normal saline.

Intervention Type DRUG

Other Intervention Names

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Normal saline

Eligibility Criteria

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Inclusion Criteria

* Nondiabetic patients with full-thickness acute wounds

Exclusion Criteria

* Diabetic patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Autonoma de San Luis Potosí

OTHER

Sponsor Role collaborator

Hospital Central "Dr. Ignacio Morones Prieto"

OTHER

Sponsor Role lead

Responsible Party

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MARIO AURELIO MARTÍNEZ-JIMÉNEZ

General Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jorge Aguilar-García, MD

Role: STUDY_CHAIR

Hospital Central "Dr. Ignacio Morones Prieto"

Locations

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Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, San Luis Potosí, Mexico

Site Status

Countries

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Mexico

References

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Martinez-Jimenez MA, Aguilar-Garcia J, Valdes-Rodriguez R, Metlich-Medlich MA, Dietsch LJP, Gaitan-Gaona FI, Kolosovas-Machuca ES, Gonzalez FJ, Sanchez-Aguilar JM. Local use of insulin in wounds of diabetic patients: higher temperature, fibrosis, and angiogenesis. Plast Reconstr Surg. 2013 Dec;132(6):1015e-1019e. doi: 10.1097/PRS.0b013e3182a806f0.

Reference Type RESULT
PMID: 24281606 (View on PubMed)

Other Identifiers

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71-13

Identifier Type: -

Identifier Source: org_study_id

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