Effects of Local Insulin on Wound Angiogenesis
- Registration Number
- NCT02396888
- Lead Sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"
- Brief Summary
Randomized, split plot, double-blind, placebo controlled trial. Half of the wounds surface was applied daily with insulin and the other half with saline solution as placebo. Biopsy specimens of the two sides were obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.
- Detailed Description
Randomized, split plot, double-blind, placebo controlled trial. Non-diabetic patients with full-thickness wounds will be treated in the following manner: in half of the surface insulin will be applied in a daily basis, on the other half, saline solution will be used as placebo. Biopsy specimens of both sides will be obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Nondiabetic patients with full-thickness acute wounds
- Diabetic patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin Insulin Half of the wound surface was treated daily with intermediate insulin. Allocation was randomized. Placebo Placebo Half of the wound surface was treated daily with normal saline. Allocation was randomized.
- Primary Outcome Measures
Name Time Method Number of blood vessels 14 days In a biopsy taken at baseline, blood vessels will be counted
- Secondary Outcome Measures
Name Time Method Hypoglycaemia 14 days Presence of capillary blood glucose of \<60 mg/dl
Related Research Topics
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Trial Locations
- Locations (1)
Hospital Central Dr. Ignacio Morones Prieto
🇲🇽San Luis Potosí, Mexico