Timolol for Diabetic Foot Ulcers (BAART-DFU Trial)

Recruiting in 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.

Participant Groups

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: