Topical Timolol Benefit in Venous Ulcers

Venous Leg Ulcers Clinical Trial

— EETUV  

Official title:

Topical Timolol Benefit in Venous Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422017
• Other study ID #: PI2014_843_0022
• Secondary ID: 2014-005046-22
• Status: Completed
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: January 2018

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2018
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcers

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	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%	12 weeks
Secondary	Complete healing	Complete healing of the ulcer i.e. 100% regression of the ulcer surface and replaced by an epidermised tissue.	12 weeks
Secondary	Tolerance (cardiac-related serious adverse events)	To assess local and cardiac safety of timolol by cardiac-related serious adverse events evaluation	12 weeks
Secondary	Quality of life evolution	Evaluation of the quality of life of patients by the Dermatology Life Quality Index (DLQI) scale at baseline and after 12 weeks of treatment	Baseline and 12 weeks