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Effects of Local Insulin on Wound Angiogenesis

Phase 3
Conditions
Angiogenesis
Interventions
Drug: Placebo
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
Inclusion Criteria
  • Nondiabetic patients with full-thickness acute wounds
Exclusion Criteria
  • Diabetic patients

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InsulinInsulinHalf of the wound surface was treated daily with intermediate insulin. Allocation was randomized.
PlaceboPlaceboHalf of the wound surface was treated daily with normal saline. Allocation was randomized.
Primary Outcome Measures
NameTimeMethod
Number of blood vessels14 days

In a biopsy taken at baseline, blood vessels will be counted

Secondary Outcome Measures
NameTimeMethod
Hypoglycaemia14 days

Presence of capillary blood glucose of \<60 mg/dl

Trial Locations

Locations (1)

Hospital Central Dr. Ignacio Morones Prieto

🇲🇽

San Luis Potosí, Mexico

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