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Timolol for Diabetic Foot Ulcers (BAART-DFU Trial)
Phase 3
Waitlist Available
Led By Sara E. Dahle, DPM MPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 31 weeks
Awards & highlights
BAART-DFU Trial Summary
This trial will test whether a safe eye drop can heal diabetic foot ulcers better than the current standard of care.
Who is the study for?
Adults with diabetic foot ulcers that are between 0.5cm2 and 20cm2 in size, have lasted more than 30 days but less than 2 years, and have an Ankle Brachial Index within a specific range can join this trial. People cannot participate if they've abused drugs recently, are pregnant without contraception use, have certain infections or immune deficiencies, received recent ulcer treatments like skin grafts or growth factors, or suffer from severe malnutrition.Check my eligibility
What is being tested?
The study is testing the effectiveness of timolol—a medication typically used as eye drops for glaucoma—applied directly to diabetic foot ulcers compared to a placebo gel. Participants will be randomly assigned to either receive the standard care plus timolol or standard care plus the non-active gel.See study design
What are the potential side effects?
Timolol may cause side effects such as fatigue, palpitations (feeling your heartbeat), shortness of breath (dyspnea), chest pain at rest (angina), and could potentially worsen heart block in those predisposed.
BAART-DFU Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 31 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~31 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measurement of timolol serum during the treatment phase
Time to complete wound closure, as assessed over a 12 week period
Secondary outcome measures
The time to wound closure between the two groups
Side effects data
From 2009 Phase 3 trial • 139 Patients • NCT007168596%
Nasopharyngitis
3%
Conjunctival hyperaemia, study eye
3%
Pyrexia
3%
Headache
3%
Rhinitis
1%
Lens dislocation, study eye
1%
Viral infection
1%
Pneumonia viral
1%
Gastroenteritis
1%
Conjunctival hyperaemia, both eyes
1%
Bronchopneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Latanoprost
Timolol
BAART-DFU Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TimololExperimental Treatment1 Intervention
Timoptic-XE plus standard of care (SOC)
Group II: SOC plus non biologically active gelPlacebo Group1 Intervention
SOC plus non biologically active gel (hydrogel as placebo medication)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Timolol
2017
Completed Phase 3
~1590
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,568 Total Patients Enrolled
6 Trials studying Foot Ulcer
1,142 Patients Enrolled for Foot Ulcer
VA Northern California Health Care SystemFED
18 Previous Clinical Trials
3,412 Total Patients Enrolled
1 Trials studying Foot Ulcer
120 Patients Enrolled for Foot Ulcer
Sara E. Dahle, DPM MPHPrincipal InvestigatorVA Northern California Health Care System, Mather, CA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and agree to use birth control during the trial.If I have two ulcers of the same size, the oldest one is my main concern.I have a non-diabetic wound like a venous, arterial, or burn wound.I have an active cancer on my foot.I experience tiredness, heart palpitations, shortness of breath, or chest pain without doing anything.You have had problems with alcohol or drug abuse, including methadone or heroin, in the past year.My study foot has more than 3 ulcers.My ulcer shows signs of severe infection or exposed bone.My blood protein levels are very low.My diabetes is not under control, with an A1C level over 12%.I have a history of serious heart rhythm problems.I am 18 years old or older.I have a foot ulcer older than 30 days but less than 2 years.I have a biopsy report for an ulcer lasting more than 6 months, confirming it's not cancer.The wound on your skin must be a certain size, between 0.5cm2 and 20cm2, and it will be measured with a special imaging system. If you have more than one wound, the largest one that meets the size requirement will be chosen as the main wound for the study. If two wounds are the same size, the one that has been there the longest will be chosen.Your immune system is not working well, as shown by low levels of certain antibodies in your blood.I was hospitalized for a diabetic foot ulcer in the last 30 days.Your blood tests show high levels of AST or ALT enzymes, which may indicate liver problems.My skin ulcer is close to another ulcer on the same limb.The wound size should be between 0.5 square centimeters and 20 square centimeters, as measured with a special imaging system. The largest wound within this size range will be chosen for the study.Your condition has lasted between 30 days and 2 years.Your ankle or toe blood pressure is within a certain range.I haven't had treatments like immunosuppressants or chemotherapy on my ulcer in the last 60 days.The size of the ulcer has changed by more than 40% between the initial assessment and the next visit.My wound is infected, as shown by symptoms or tests.You have HIV.
Research Study Groups:
This trial has the following groups:- Group 1: SOC plus non biologically active gel
- Group 2: Timolol
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open positions for individuals in this clinical trial?
"No, this particular clinical trial is no longer recruiting patients, as reported on the clinicaltrials.gov website. The study was first posted on 6/14/2018, and the most recent update was on 10/6/2022. However, there are 413 other clinical trials that are actively looking for participants."
Answered by AI
Is there precedent for Timolol's effectiveness?
"At the moment, there are 9 ongoing clinical trials studying the efficacy of Timolol. Of these trials, 4 are in Phase 3. Most of the research is taking place in Campinas, São Paulo; however, there are 15 total locations running trials for Timolol."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
VA Northern California Health Care System, Mather, CA
What portion of applicants met pre-screening criteria?
Met criteria
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