NCT02422017

Topical Timolol Benefit in Venous Ulcers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Venous Leg Ulcers

Interventions

Type	Name	Description
DRUG	Timolol	Patients will receive one drop of timolol every 6cm ² every other day for twelve weeks applied on the ulcer of interest
OTHER	Local care treatment	Local care treatment with dressing compression in accordance with standards applied every other day

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-05-01
• Completion: 2018-01-01
• First posted: 2015-04-21
• Last updated: 2025-09-19

Locations

1 site across 1 country: France