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Effects of Local Insulin on Varicose Ulcers for Wound Healing

NCT04310280 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-03-17

No results posted yet for this study

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.

Conditions

  • Chronic Venous Disease
  • Varicose Ulcer
  • Wound Healing
  • Insulin
  • Angiogenesis

Interventions

DRUG

Insulin Glargine

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

DRUG

Saline

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

Sponsors & Collaborators

  • Hospital Central "Dr. Ignacio Morones Prieto"

    lead OTHER

Principal Investigators

  • Jose L Ramirez-GarciaLuna, MD, PhD · Universidad Autónoma de San Luis Potosí

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2019-12-31
Completion
2020-02-15

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04310280 on ClinicalTrials.gov