Topical Timolol Benefit in Venous Ulcers (EETUV)

August 2, 2018 updated by: Centre Hospitalier Universitaire, Amiens

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Timolol
Patients will receive one drop of timolol every 6cm ² every other day for twelve weeks in combination with dressings and compression.
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 Names:
  • Timoptol
Other: Local care treatment
Local care treatment with dressing compression in accordance with standards applied every other day
Other: Control
Local care treatment only (dressing and compression applied every other day)
Other: Local care treatment
Local care treatment with dressing compression in accordance with standards applied every other day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete healing
Time Frame: 12 weeks
Complete healing of the ulcer i.e. 100% regression of the ulcer surface and replaced by an epidermised tissue.
12 weeks
Tolerance (cardiac-related serious adverse events)
Time Frame: 12 weeks
To assess local and cardiac safety of timolol by cardiac-related serious adverse events evaluation
12 weeks
Quality of life evolution
Time Frame: Baseline and 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2014_843_0022
  • 2014-005046-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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