Effects of Local Insulin on Varicose Ulcers for Wound Healing

Phase 3

Completed

• Conditions: Chronic Venous Disease; Varicose Ulcer; Insulin; Wound Healing; Angiogenesis
• Interventions: Drug: Saline; Drug: Insulin Glargine

• Registration Number: NCT04310280
• Lead Sponsor: Hospital Central "Dr. Ignacio Morones Prieto"

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.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-02-15
• Status Verified: 2020-03
• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-14
• Last Update Submitted: 2020-03-14
• Study First Posted: 2020-03-17
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% saline solution	Saline	The wound surface is treated with conventional wound care in a daily matter for 7 days. Allocation is randomized.
Topical insulin glargine	Insulin Glargine	The wound surface is treated locally with glargine insulin injected sub-dermal in a daily matter for 7 days. Allocation is randomized.

Primary Outcome Measures

Name	Time	Method
Final angiogenesis	Day 7	Number of blood vessels in a skin biopsy

Secondary Outcome Measures

Name	Time	Method
Fibroplasia	Day 7	Percentage of fibrous tissue in a skin biopsy
Thermal asymmetry	Day 7	Difference between the temperature of the wound and the surrounding healthy tissue
Hypoglycaemia	Day 7	Presence of capillary blood glucose of \<60 mg/dl or clinical symptoms of hypoglycemia

Trial Locations

Locations (1)

Mario Aurelio Martínez-Jiménez; 🇲🇽 San Luis Potosí, San Luis Potosi, Mexico