Topical Timolol Benefit in Venous Ulcers

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire, Amiens
• Treatments: Timolol

Criteria

Inclusion Criteria:

• Affiliated to a social security scheme patients

• Informed consent

• Patients over 18 years

• Ulcer lasting for at least 24 weeks with no improvement observed after 4 weeks of well conducted treatment (compression and local care)

• Presence of one or more venous leg ulcers (objectified by a Doppler ultrasound dated within 6 months and ABPI ≥ 0.8)

• Ulcers with a surface of 5 to 50 cm ² and at granulation stage

• Study ulcer must be at least 2 cm from Any Other ulcer on same extremity.

• If several ulcers present, the greatest is selected

• Granulation tissue ≥ 50%

Exclusion Criteria:

• Minors under guardianship, deprived of liberty, not looking at treatment, lack of signed consent, pregnant women, demented patients

• Ulcer lasting for less than 24 weeks

• Granulation tissue <50%

• Obliterative arteritis (ABPI <0.8)

• Infection of the ulcer (need to treat the infection before any inclusion criteria be compatible)

• Non-cardioselective beta-blocker treatment

• Bradycardiac treatment

• Patients under diltiazem, verapamil (calcium antagonists)

• Reaching underlying noble structures, tumor acutisation wound

• Immunosuppression

• Diabetes unbalanced (HbA1c> 8%)

• Severe Malnutrition (albumin <25g / L)

• Anemia <10g/dl

• Contraindication to beta-blockers