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Topical Timolol Benefit in Venous Ulcers (EETUV)

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ClinicalTrials.gov Identifier: NCT02422017
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.


Condition or disease Intervention/treatment Phase
Venous Leg Ulcers Drug: Timolol Other: Local care treatment Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical Timolol Benefit in Venous Ulcers
Study Start Date : April 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


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 Name: Timoptol

Other: Local care treatment
Local care treatment with dressing compression in accordance with standards applied every other day

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422017


Locations
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France
CHU Amiens
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02422017    
Other Study ID Numbers: PI2014_843_0022
2014-005046-22 ( EudraCT Number )
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Leg ulcer
wound
topical timolol
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Timolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents