Clinical trial NCT04310280: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Venous Disease
Varicose Ulcer
Wound Healing
Insulin
Angiogenesis
Keywords: Varicose Ulcer
Wound Healing
Insulin
Angiogenesis
Lead sponsor: Hospital Central "Dr. Ignacio Morones Prieto"
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment Randomized split-plot design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Final angiogenesis
timeFrame: Day 7
Secondary outcomes:
measure: Fibroplasia
timeFrame: Day 7
measure: Thermal asymmetry
timeFrame: Day 7
measure: Hypoglycaemia
timeFrame: Day 7
Other outcomes:
Locations:
city: San Luis Potosí
country: Mexico
facility: Mario Aurelio Martínez-Jiménez
state: San Luis Potosi
Study officials:
affiliation: Universidad Autónoma de San Luis Potosí
name: Jose L Ramirez-GarciaLuna, MD, PhD
role: STUDY_CHAIR
References:
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.
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.