Wound Healing Clinical Trial
Official title:
Effects of Local Insulin on Wound Angiogenesis and Fibroplasia in Varicose Ulcers
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.
A randomized, split-plot, double-blind, placebo-controlled trial. Chronic Varicose Ulcers
measuring more than 4 cm in any of its dimensions, and that comply with candidate criteria
are included in the present study. A split-mouth model is used.
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.
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