Venous Leg UlcersPhase 2EETUVNCT02422017
Topical Timolol Benefit in Venous Ulcers
A Phase 2 study testing Timolol and Local care treatment in people with Venous Leg Ulcers, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcers
- What is being tested?
- Timolol and Local care treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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%
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Venous Leg Ulcers
- Being tested
- Timolol, Local care treatment
- Keywords
- Leg ulcer, wound, topical timolol
- Medical subject headings
- Leg Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TimololDrug
Also called Timoptol
Patients will receive one drop of timolol every 6cm ² every other day for twelve weeks applied on the ulcer of interest
Local care treatmentOther
Local care treatment with dressing compression in accordance with standards applied every other day
| Study group | Role | What they receive |
|---|---|---|
| Timolol | Experimental | Patients will receive one drop of timolol every 6cm ² every other day for twelve weeks in combination with dressings and compression. Receives: Drug: Timolol; Other: Local care treatment |
| Control | Other | Local care treatment only (dressing and compression applied every other day) Receives: Other: Local care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 12 weeks
Secondary outcomes (3)
Complete healing
Complete healing of the ulcer i.e. 100% regression of the ulcer surface and replaced by an epidermised tissue.
Measured: 12 weeks
Tolerance (cardiac-related serious adverse events)
To assess local and cardiac safety of timolol by cardiac-related serious adverse events evaluation
Measured: 12 weeks
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
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous Leg UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422017
- Sponsor's protocol ID
- PI2014_843_0022
- Other IDs
- 2014-005046-22, 2014
- Acronym
- EETUV
- Status last verified
- Sep 2025
- First submitted
- 13 Apr 2015
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33551214
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Timolol Benefit in Venous Ulcers
- ClinicalTrials.gov ID
- NCT02422017
- Acronym / sponsor ID
- EETUV / PI2014_843_0022
- Conditions
- Venous Leg Ulcers
- Keywords
- Leg ulcer, wound, topical timolol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Timolol | Experimental | Drug: Timolol, Other: Local care treatmentPatients will receive one drop of timolol every 6cm ² every other day for twelve weeks in combination with dressings and compression. |
| Control | Other | Other: Local care treatmentLocal care treatment only (dressing and compression applied every other day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TimololAlso: TimoptolPatients will receive one drop of timolol every 6cm ² every other day for twelve weeks applied on the ulcer of interest | Drug | Timolol |
| Local care treatmentLocal care treatment with dressing compression in accordance with standards applied every other day | Other | Control, Timolol |
Primary outcome
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%
3 secondary outcomes
Complete healing
Time frame: 12 weeks
Tolerance (cardiac-related serious adverse events)
Time frame: 12 weeks
Quality of life evolution
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 33551214Baltazard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Timolol and Local care treatment in people with Venous Leg Ulcers, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02422017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.