search
Back to results

Topical Timolol Benefit in Venous Ulcers (EETUV)

Primary Purpose

Venous Leg Ulcers

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Timolol
Local care treatment
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcers focused on measuring Leg ulcer, wound, topical timolol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Timolol

Control

Arm Description

Patients will receive one drop of timolol every 6cm ² every other day for twelve weeks in combination with dressings and compression.

Local care treatment only (dressing and compression applied every other day)

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

Complete healing
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)
To assess local and cardiac safety of timolol by cardiac-related serious adverse events evaluation
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

Full Information

First Posted
April 13, 2015
Last Updated
August 2, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
search

1. Study Identification

Unique Protocol Identification Number
NCT02422017
Brief Title
Topical Timolol Benefit in Venous Ulcers
Acronym
EETUV
Official Title
Topical Timolol Benefit in Venous Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcers
Keywords
Leg ulcer, wound, topical timolol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Timolol
Arm Type
Experimental
Arm Description
Patients will receive one drop of timolol every 6cm ² every other day for twelve weeks in combination with dressings and compression.
Arm Title
Control
Arm Type
Other
Arm Description
Local care treatment only (dressing and compression applied every other day)
Intervention Type
Drug
Intervention Name(s)
Timolol
Other Intervention Name(s)
Timoptol
Intervention Description
Patients will receive one drop of timolol every 6cm ² every other day for twelve weeks applied on the ulcer of interest
Intervention Type
Other
Intervention Name(s)
Local care treatment
Intervention Description
Local care treatment with dressing compression in accordance with standards applied every other day
Primary Outcome Measure Information:
Title
Success rate
Description
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%
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Complete healing
Description
Complete healing of the ulcer i.e. 100% regression of the ulcer surface and replaced by an epidermised tissue.
Time Frame
12 weeks
Title
Tolerance (cardiac-related serious adverse events)
Description
To assess local and cardiac safety of timolol by cardiac-related serious adverse events evaluation
Time Frame
12 weeks
Title
Quality of life evolution
Description
Evaluation of the quality of life of patients by the Dermatology Life Quality Index (DLQI) scale at baseline and after 12 weeks of treatment
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Learn more about this trial

Topical Timolol Benefit in Venous Ulcers

We'll reach out to this number within 24 hrs