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Topical Timolol Benefit in Venous Ulcers (EETUV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 13, 2015
First Posted Date  ICMJE April 21, 2015
Last Update Posted Date August 3, 2018
Study Start Date  ICMJE April 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
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%
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2016)
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
  • 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.
  • Tolerance (cardiac-related serious adverse events) [ Time Frame: 12 weeks ]
    To assess local and cardiac safety of timolol by cardiac-related serious adverse events evalution
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Timolol Benefit in Venous Ulcers
Official Title  ICMJE Topical Timolol Benefit in Venous Ulcers
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Venous Leg Ulcers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Timolol
    Patients will receive one drop of timolol every 6cm ² every other day for twelve weeks in combination with dressings and compression.
    Interventions:
    • Drug: Timolol
    • Other: Local care treatment
  • Control
    Local care treatment only (dressing and compression applied every other day)
    Intervention: Other: Local care treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2018)
42
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2015)
48
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02422017
Other Study ID Numbers  ICMJE PI2014_843_0022
2014-005046-22 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor  ICMJE Centre Hospitalier Universitaire, Amiens
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP