Effects of Local Insulin on Wound Angiogenesis

March 18, 2015 updated by: MARIO AURELIO MARTÍNEZ-JIMÉNEZ, Hospital Central "Dr. Ignacio Morones Prieto"

Effects of Local Insulin on Angiogenesis in Acute Wounds in Non-diabetic Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • San Luis Potosí, Mexico, 78290
        • Hospital Central Dr. Ignacio Morones Prieto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Nondiabetic patients with full-thickness acute wounds

Exclusion Criteria:

  • Diabetic patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin
Half of the wound surface was treated daily with intermediate insulin. Allocation was randomized.
Drug: Insulin
Half of the wound surface was treated daily with 10 units of intermediate insulin.
Placebo Comparator: Placebo
Half of the wound surface was treated daily with normal saline. Allocation was randomized.
Drug: Placebo
Half of the wound surface was treated daily with 0.1 cc of normal saline.
Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of blood vessels
Time Frame: 14 days
In a biopsy taken at baseline, blood vessels will be counted
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoglycaemia
Time Frame: 14 days
Presence of capillary blood glucose of <60 mg/dl
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Central "Dr. Ignacio Morones Prieto"

Collaborators

Universidad Autonoma de San Luis Potosí

Investigators

  • Study Chair: Jorge Aguilar-García, MD, Hospital Central "Dr. Ignacio Morones Prieto"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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