Wound Healing Clinical Trial
Official title:
Effects of Local Insulin on Wound Angiogenesis and Fibroplasia in Varicose Ulcers
Verified date | March 2020 |
Source | Hospital Central "Dr. Ignacio Morones Prieto" |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | February 15, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Mario Aurelio Martínez-Jiménez | San Luis Potosí | San Luis Potosi |
Lead Sponsor | Collaborator |
---|---|
Hospital Central "Dr. Ignacio Morones Prieto" |
Mexico,
Martínez-Jiménez MA, Aguilar-García J, Valdés-Rodríguez R, Metlich-Medlich MA, Dietsch LJ, Gaitán-Gaona FI, Kolosovas-Machuca ES, González FJ, Sánchez-Aguilar JM. Local use of insulin in wounds of diabetic patients: higher temperature, fibrosis, and angio — View Citation
Martínez-Jiménez MA, Valadez-Castillo FJ, Aguilar-García J, Ramírez-GarciaLuna JL, Gaitán-Gaona FI, Pierdant-Perez M, Valdes-Rodríguez R, Sánchez-Aguilar JM. Effects of Local Use of Insulin on Wound Healing in Non-diabetic Patients. Plast Surg (Oakv). 201 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Final angiogenesis | Number of blood vessels in a skin biopsy | Day 7 | |
Secondary | Fibroplasia | Percentage of fibrous tissue in a skin biopsy | Day 7 | |
Secondary | Thermal asymmetry | Difference between the temperature of the wound and the surrounding healthy tissue | Day 7 | |
Secondary | Hypoglycaemia | Presence of capillary blood glucose of <60 mg/dl or clinical symptoms of hypoglycemia | Day 7 |
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