NCT04310280

Brief Summary

A randomized, split-plot, double-blind, placebo-controlled trial. The varicose ulcer is divided into two (side A and B). Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Treatment with insulin is administered for 7 days. Biopsy specimens of the two sides are obtained on days 0 and 7. A thermographic photograph of the wound is taken at days 0 and 7. The number of blood vessels and fibroplasia is evaluated as the main outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

March 11, 2020

Last Update Submit

March 14, 2020

Conditions

Chronic Venous DiseaseVaricose UlcerWound HealingInsulinAngiogenesis

Keywords

Varicose UlcerWound HealingInsulinAngiogenesis

Outcome Measures

Primary Outcomes (1)

  • Final angiogenesis

    Number of blood vessels in a skin biopsy

    Day 7

Secondary Outcomes (3)

  • Fibroplasia

    Day 7

  • Thermal asymmetry

    Day 7

  • Hypoglycaemia

    Day 7

Study Arms (2)

Topical insulin glargine

EXPERIMENTAL

The wound surface is treated locally with glargine insulin injected sub-dermal in a daily matter for 7 days. Allocation is randomized.

Drug: Insulin Glargine

0.9% saline solution

PLACEBO COMPARATOR

The wound surface is treated with conventional wound care in a daily matter for 7 days. Allocation is randomized.

Drug: Saline

Interventions

Insulin GlargineDRUG

Half of the wound surface is injected daily with topical glargine insulin

Topical insulin glargine
SalineDRUG

Half of the wound surface is injected daily with topical saline solution

0.9% saline solution

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any gender
  • Presence of varicose ulcer in lower extremities with a size greater than 25 cm2
  • Absence of infection

You may not qualify if:

  • Presence of diabetes or glycated hemoglobin \>6.5%
  • Comorbidities that affect wound healing
  • Malnutrition
  • Active smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mario Aurelio Martínez-Jiménez

San Luis Potosí City, San Luis Potosí, 78220, Mexico

Location

Related Publications (3)

  • Martinez-Jimenez MA, Valadez-Castillo FJ, Aguilar-Garcia J, Ramirez-GarciaLuna JL, Gaitan-Gaona FI, Pierdant-Perez M, Valdes-Rodriguez R, Sanchez-Aguilar JM. Effects of Local Use of Insulin on Wound Healing in Non-diabetic Patients. Plast Surg (Oakv). 2018 May;26(2):75-79. doi: 10.1177/2292550317740688. Epub 2017 Nov 22.

    PMID: 29845043RESULT

  • 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

  • Martinez-Jimenez MA, Kolosovas-Machuca S, Alcocer F, Ortiz-Dosal LC, Gonzalez-Grijalva MC, Delsol-Revuelta GA, Gaitan-Gaona FI, Valadez-Castillo FJ, Ramirez-GarciaLuna JL. A Randomized Controlled Trial on the Effect of Local Insulin Glargine on Venous Ulcer Healing. J Surg Res. 2022 Nov;279:657-665. doi: 10.1016/j.jss.2022.06.070. Epub 2022 Aug 3.

    PMID: 35932720DERIVED

MeSH Terms

Conditions

Varicose UlcerInsulin Resistance

Interventions

Insulin GlargineSodium Chloride

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jose L Ramirez-GarciaLuna, MD, PhD

    Universidad Autonoma de San Luis Potosí

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double (Participant, Investigator) Double Blind (Participant, Investigator)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment Randomized split-plot design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 17, 2020

Study Start

June 1, 2019

Primary Completion

December 31, 2019

Study Completion

February 15, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Anonymized data will be available upon request after the publication of results.

Locations

ME(1)