Topical Timolol Benefit in Venous Ulcers
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Success rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Timolol
Patients will receive one drop of timolol every 6cm ² every other day for twelve weeks in combination with dressings and compression.
Intervention: Timolol (Drug)
Timolol
Patients will receive one drop of timolol every 6cm ² every other day for twelve weeks in combination with dressings and compression.
Intervention: Local care treatment (Other)
Control
Local care treatment only (dressing and compression applied every other day)
Intervention: Local care treatment (Other)
Outcomes
Primary Outcomes
Success rate
Time Frame: 12 weeks
Assess the healing rate in patients treated with topical timolol associated with wound dressing and compression for 12 weeks, compared to patients treated with wound dressing and compression. Success is defined as an ulcer surface relative reduction \>= 40%
Secondary Outcomes
- Complete healing(12 weeks)
- Tolerance (cardiac-related serious adverse events)(12 weeks)
- Quality of life evolution(Baseline and 12 weeks)