drugset / Trial / NCT04310280
Effects of Local Insulin on Varicose Ulcers for Wound Healing
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2019-06-01
- Primary completion
- 2019-12-31
- Completion
- 2020-02-15
Publications
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin glargine | Protein / enzyme biologic | 10 iu | Subcutaneous |