Effects of Local Insulin on Varicose Ulcers for Wound Healing
NCT ID: NCT04310280
Last Updated: 2020-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
13 participants
INTERVENTIONAL
2019-06-01
2020-02-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Insulin Glargine
Half of the wound surface is injected daily with topical glargine insulin
0.9% saline solution
The wound surface is treated with conventional wound care in a daily matter for 7 days. Allocation is randomized.
Saline
Half of the wound surface is injected daily with topical saline solution
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Presence of varicose ulcer in lower extremities with a size greater than 25 cm2
* Absence of infection
Exclusion Criteria
* Comorbidities that affect wound healing
* Malnutrition
* Active smoking
18 Years
85 Years
ALL
No
Sponsors
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Hospital Central "Dr. Ignacio Morones Prieto"
OTHER
Responsible Party
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MARIO AURELIO MARTÍNEZ-JIMÉNEZ
Professor
Principal Investigators
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Jose L Ramirez-GarciaLuna, MD, PhD
Role: STUDY_CHAIR
Universidad Autónoma de San Luis Potosí
Locations
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Mario Aurelio Martínez-Jiménez
San Luis Potosí City, San Luis Potosí, Mexico
Countries
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References
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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.
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.
Martinez-Jimenez MA, Kolosovas-Machuca S, Alcocer F, Ortiz-Dosal LC, Gonzalez-Grijalva MC, Delsol-Revuelta GA, Gaitan-Gaona FI, Valadez-Castillo FJ, Ramirez-GarciaLuna JL. A Randomized Controlled Trial on the Effect of Local Insulin Glargine on Venous Ulcer Healing. J Surg Res. 2022 Nov;279:657-665. doi: 10.1016/j.jss.2022.06.070. Epub 2022 Aug 3.
Other Identifiers
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01-17
Identifier Type: -
Identifier Source: org_study_id
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