NCT02422017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

April 13, 2015

Last Update Submit

September 16, 2025

Conditions

Venous Leg Ulcers

Keywords

Leg ulcerwoundtopical timolol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Complete healing

    12 weeks

  • Tolerance (cardiac-related serious adverse events)

    12 weeks

  • Quality of life evolution

    Baseline and 12 weeks

Study Arms (2)

Timolol

EXPERIMENTAL

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

Drug: TimololOther: Local care treatment

Control

OTHER

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

Other: Local care treatment

Interventions

TimololDRUG

Patients will receive one drop of timolol every 6cm ² every other day for twelve weeks applied on the ulcer of interest

Also known as: Timoptol
Timolol
Local care treatmentOTHER

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

ControlTimolol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

Related Publications (1)

  • Baltazard T, Senet P, Momar D, Picard C, Joachim C, Adas A, Lok C, Chaby G. Evaluation of timolol maleate gel for management of hard-to-heal chronic venous leg ulcers. Phase II randomised-controlled study. Ann Dermatol Venereol. 2021 Dec;148(4):228-232. doi: 10.1016/j.annder.2020.11.009. Epub 2021 Feb 4.

    PMID: 33551214RESULT

MeSH Terms

Conditions

Leg UlcerWounds and Injuries

Interventions

Timolol

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 21, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2016

Study Completion

January 1, 2018

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

FR(1)