Effects of Local Insulin on Varicose Ulcers for Wound Healing

Sponsor

Hospital Central "Dr. Ignacio Morones Prieto" (Other)

Overall Status

Completed

CT.gov ID

NCT04310280

Collaborator

(none)

Enrollment

Location

Arms

8.5

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Venous Disease Varicose Ulcer Wound Healing Insulin Angiogenesis	Drug: Insulin Glargine Drug: Saline	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel assignment Randomized split-plot designParallel assignment Randomized split-plot design

Masking:

Double (Participant, Investigator)

Masking Description:

Double (Participant, Investigator) Double Blind (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Feb 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Topical insulin glargine 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 Half of the wound surface is injected daily with topical glargine insulin
Placebo Comparator: 0.9% saline solution The wound surface is treated with conventional wound care in a daily matter for 7 days. Allocation is randomized.	Drug: Saline Half of the wound surface is injected daily with topical saline solution

Arm

Intervention/Treatment

Experimental: Topical insulin glargine

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

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

Placebo Comparator: 0.9% saline solution

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

Drug: Saline

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

Outcome Measures

Primary Outcome Measures

Final angiogenesis [Day 7]
Number of blood vessels in a skin biopsy

Secondary Outcome Measures

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