~5 spots leftby Mar 2026

Timolol for Diabetic Foot Ulcers (BAART-DFU Trial)

Palo Alto (17 mi)
Overseen bySara E. Dahle, DPM MPH
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: VA Office of Research and Development
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing if timolol, an eye drop medicine, can help heal diabetic foot ulcers. The study focuses on Veterans with these ulcers because they are hard to treat and can lead to amputations. Timolol might help wounds heal faster when applied directly to them.

Eligibility Criteria

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.

Exclusion Criteria

I am not pregnant and agree to use birth control during the trial.
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.
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.
My skin ulcer is close to another ulcer on the same limb.
I haven't had treatments like immunosuppressants or chemotherapy on my ulcer in the last 60 days.
My wound is infected, as shown by symptoms or tests.

Treatment Details

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.
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)
Timolol is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Timoptic for:
  • Glaucoma
  • Ocular hypertension
🇪🇺 Approved in European Union as Timoptol for:
  • Glaucoma
  • Ocular hypertension
🇨🇦 Approved in Canada as Timoptic for:
  • Glaucoma
  • Ocular hypertension
🇦🇺 Approved in Australia as Timoptol for:
  • Glaucoma
  • Ocular hypertension
  • Infantile hemangioma (off-label)

Find a clinic near you

Research locations nearbySelect from list below to view details:
VA Northern California Health Care System, Mather, CASacramento, CA
Loading ...

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
VA Northern California Health Care SystemCollaborator

References