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Effects of Local Insulin on Varicose Ulcers for Wound Healing

Primary Purpose

Chronic Venous Disease, Varicose Ulcer, Wound Healing

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Insulin Glargine
Saline
Sponsored by
Hospital Central "Dr. Ignacio Morones Prieto"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Venous Disease focused on measuring Varicose Ulcer, Wound Healing, Insulin, Angiogenesis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Mario Aurelio Martínez-Jiménez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Topical insulin glargine

0.9% saline solution

Arm Description

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

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

Outcomes

Primary Outcome Measures

Final angiogenesis
Number of blood vessels in a skin biopsy

Secondary Outcome Measures

Fibroplasia
Percentage of fibrous tissue in a skin biopsy
Thermal asymmetry
Difference between the temperature of the wound and the surrounding healthy tissue
Hypoglycaemia
Presence of capillary blood glucose of <60 mg/dl or clinical symptoms of hypoglycemia

Full Information

First Posted
March 11, 2020
Last Updated
March 14, 2020
Sponsor
Hospital Central "Dr. Ignacio Morones Prieto"
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1. Study Identification

Unique Protocol Identification Number
NCT04310280
Brief Title
Effects of Local Insulin on Varicose Ulcers for Wound Healing
Official Title
Effects of Local Insulin on Wound Angiogenesis and Fibroplasia in Varicose Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Central "Dr. Ignacio Morones Prieto"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
A randomized, split-plot, double-blind, placebo-controlled trial. Chronic Varicose Ulcers measuring more than 4 cm in any of its dimensions, and that comply with candidate criteria are included in the present study. A split-mouth model is used. The ulcer is divided into two (sides A and B). The side in which treatment is applied is randomized. Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Both halves are covered with dressings and compression therapy is applied. 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, as control of the local temperature of the wound. This is to asses the process of healing and to correlate with our outcome measures. The number of blood vessels will be evaluated as the main outcome. Fibroplasia and thermal asymmetry between wound sides will be evaluated as secondary outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Disease, Varicose Ulcer, Wound Healing, Insulin, Angiogenesis
Keywords
Varicose Ulcer, Wound Healing, Insulin, Angiogenesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment Randomized split-plot design
Masking
ParticipantInvestigator
Masking Description
Double (Participant, Investigator) Double Blind (Participant, Investigator)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical insulin glargine
Arm Type
Experimental
Arm Description
The wound surface is treated locally with glargine insulin injected sub-dermal in a daily matter for 7 days. Allocation is randomized.
Arm Title
0.9% saline solution
Arm Type
Placebo Comparator
Arm Description
The wound surface is treated with conventional wound care in a daily matter for 7 days. Allocation is randomized.
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Intervention Description
Half of the wound surface is injected daily with topical glargine insulin
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Half of the wound surface is injected daily with topical saline solution
Primary Outcome Measure Information:
Title
Final angiogenesis
Description
Number of blood vessels in a skin biopsy
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Fibroplasia
Description
Percentage of fibrous tissue in a skin biopsy
Time Frame
Day 7
Title
Thermal asymmetry
Description
Difference between the temperature of the wound and the surrounding healthy tissue
Time Frame
Day 7
Title
Hypoglycaemia
Description
Presence of capillary blood glucose of <60 mg/dl or clinical symptoms of hypoglycemia
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any gender Presence of varicose ulcer in lower extremities with a size greater than 25 cm2 Absence of infection Exclusion Criteria: Presence of diabetes or glycated hemoglobin >6.5% Comorbidities that affect wound healing Malnutrition Active smoking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose L Ramirez-GarciaLuna, MD, PhD
Organizational Affiliation
Universidad Autónoma de San Luis Potosí
Official's Role
Study Chair
Facility Information:
Facility Name
Mario Aurelio Martínez-Jiménez
City
San Luis Potosí
State/Province
San Luis Potosi
ZIP/Postal Code
78220
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Anonymized data will be available upon request after the publication of results.
Citations:
PubMed Identifier
29845043
Citation
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.
Results Reference
result
PubMed Identifier
24281606
Citation
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.
Results Reference
result

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Effects of Local Insulin on Varicose Ulcers for Wound Healing

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