Venous Leg Ulcers Clinical Trial
Official title:
Topical Timolol Benefit in Venous Ulcers
Background: Venous Leg ulcers are a frequent pathology in dermatology and complex in their
management. At the origin of high health costs and strong repercussions on quality of life
for patients, they require long management and may be subject to possible complications.
In spite of appropriate treatment, 50-60% of these ulcers are not healed at 24 weeks.
Purpose: Topical beta adrenergic antagonists have shown efficacy in wound healing. The
purpose of this study is to evaluate the efficacy and safety of treatment of chronic venous
ulcers with topical timolol.
Abstract: Complicating severe stages of chronic venous insufficiency, venous leg ulcers are
common in dermatology and responsible for important health care costs. Healing remains long
with many persistent cases after one year, despite compression and local dressings. Several
pharmacological studies have demonstrated a benefit of beta-blockers on the wound healing
process: present in the skin, the beta-adrenergic receptors play a role in wound healing.
Their stimulation inhibits healing while blocking them promotes angiogenesis, fibroblast
migration and keratinocyte migration. Using the topical timolol in several patients seems to
confirm these effects: all ulcers treated with timolol healed in a few weeks whereas they did
not evolve under local care and compression.
The purpose of this study is to demonstrate whether there is an interest in topical timolol
for venous leg ulcers in combination with compression and wound dressings versus placebo. The
primary endpoint is to evaluate the healing rate to W12. The effects will be evaluated with
photography, evaluation of the surface of the ulcer at W12 compared to W0. The research of
side effects will also be evaluated.
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