NCT02396888

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

6 months

First QC Date

March 6, 2015

Last Update Submit

March 18, 2015

Conditions

Angiogenesis

Keywords

Blood vesselFibroplasiaWound healingInsulin

Outcome Measures

Primary Outcomes (1)

  • Number of blood vessels

    In a biopsy taken at baseline, blood vessels will be counted

    14 days

Secondary Outcomes (1)

  • Hypoglycaemia

    14 days

Study Arms (2)

Insulin

EXPERIMENTAL

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

Drug: Insulin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

InsulinDRUG

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

Insulin
PlaceboDRUG

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

Also known as: Normal saline
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nondiabetic patients with full-thickness acute wounds

You may not qualify if:

  • Diabetic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, San Luis Potosí, 78290, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 24281606RESULT

MeSH Terms

Conditions

FibrosisInsulin Resistance

Interventions

InsulinSaline Solution

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Jorge Aguilar-García, MD

    Hospital Central "Dr. Ignacio Morones Prieto"

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon

Study Record Dates

First Submitted

March 6, 2015

First Posted

March 24, 2015

Study Start

October 1, 2014

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

ME(1)