Effects of Local Insulin on Varicose Ulcers for Wound Healing

Wound Healing Clinical Trial

Official title:

Effects of Local Insulin on Wound Angiogenesis and Fibroplasia in Varicose Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04310280
• Other study ID #: 01-17
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2019
• Est. completion date: February 15, 2020

Study information

• Verified date: March 2020
• Source: Hospital Central "Dr. Ignacio Morones Prieto"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 15, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Angiogenesis
• Chronic Venous Disease
• Insulin
• Ulcer
• Varicose Ulcer
• Wound Healing
• Wounds and Injuries

Intervention

Drug:
• Insulin Glargine
Half of the wound surface is injected daily with topical glargine insulin
• Saline
Half of the wound surface is injected daily with topical saline solution

Locations

Country	Name	City	State
Mexico	Mario Aurelio Martínez-Jiménez	San Luis Potosí	San Luis Potosi

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Central "Dr. Ignacio Morones Prieto"

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

Martínez-Jiménez MA, Aguilar-García J, Valdés-Rodríguez R, Metlich-Medlich MA, Dietsch LJ, Gaitán-Gaona FI, Kolosovas-Machuca ES, González FJ, Sánchez-Aguilar JM. Local use of insulin in wounds of diabetic patients: higher temperature, fibrosis, and angio — View Citation

Martínez-Jiménez MA, Valadez-Castillo FJ, Aguilar-García J, Ramírez-GarciaLuna JL, Gaitán-Gaona FI, Pierdant-Perez M, Valdes-Rodríguez R, Sánchez-Aguilar JM. Effects of Local Use of Insulin on Wound Healing in Non-diabetic Patients. Plast Surg (Oakv). 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final angiogenesis	Number of blood vessels in a skin biopsy	Day 7
Secondary	Fibroplasia	Percentage of fibrous tissue in a skin biopsy	Day 7
Secondary	Thermal asymmetry	Difference between the temperature of the wound and the surrounding healthy tissue	Day 7
Secondary	Hypoglycaemia	Presence of capillary blood glucose of <60 mg/dl or clinical symptoms of hypoglycemia	Day 7