What side effects are associated with this type of intervention?

Common treatments for diabetic foot ulcers include advanced wound dressings, debridement, antibiotics, and offloading devices. For treatments similar to Timolol, which is a beta-adrenergic receptor blocker, side effects are generally minimal when used topically. However, systemic absorption can potentially lead to side effects such as bradycardia, hypotension, and bronchospasm. In the context of wound healing, these side effects are less common but should be monitored. Other common treatments may cause local irritation, allergic reactions, or infection at the application site.

What prior FDA approvals exist?

The FDA has approved various treatments for diabetic foot ulcers, including advanced wound care products like hydrogels, growth factors, and skin substitutes. However, there is limited information on the approval of beta-adrenergic receptor blockers like Timolol specifically for foot ulcer treatment. Timolol, primarily used as an eye drop for glaucoma, is being studied for its potential to promote wound healing in diabetic foot ulcers, but it has not yet received FDA approval for this indication.

What other types of research exist?

Promising alternatives to Timolol for diabetic foot ulcer treatment include: <ol> <li>Platelet-Rich Plasma (PRP) Therapy: Utilizes the patient's own blood components to promote healing and tissue regeneration.</li> <li></li> </ol> Stem Cell Therapy: Involves the use of stem cells to enhance tissue repair and regeneration. 3. Hyperbaric Oxygen Therapy (HBOT): Increases oxygen supply to the wound, promoting faster healing. 4. Growth Factor Therapy: Uses growth factors like PDGF (platelet-derived growth factor) to stimulate cell growth and wound healing. 5. Advanced Wound Dressings: Includes dressings with antimicrobial properties, moisture control, and bioactive components to support healing.

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Beta Blocker

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

Must not have

Female who is pregnant or refuses to use adequate contraceptive methods and is of childbearing age during the trial

Ulcer of non-diabetic etiology, such as venous, arterial and burn wounds

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 31 weeks

Awards & highlights

Pivotal Trial

Summary

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.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant and agree to use birth control during the trial.

Select...

I have a non-diabetic wound like a venous, arterial, or burn wound.

Select...

I have an active cancer on my foot.

Select...

I experience tiredness, heart palpitations, shortness of breath, or chest pain without doing anything.

Select...

My study foot has more than 3 ulcers.

Select...

My ulcer shows signs of severe infection or exposed bone.

Select...

My blood protein levels are very low.

Select...

My diabetes is not under control, with an A1C level over 12%.

Select...

I have a history of serious heart rhythm problems.

Select...

My skin ulcer is close to another ulcer on the same limb.

Select...

I haven't had treatments like immunosuppressants or chemotherapy on my ulcer in the last 60 days.

Select...

My wound is infected, as shown by symptoms or tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 31 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~31 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 31 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measurement of timolol serum during the treatment phase

Time to complete wound closure, as assessed over a 12 week period

Side effects data

From 2009 Phase 3 trial • 139 Patients • NCT00716859

Nasopharyngitis

Influenza

Headache

Conjunctival hyperaemia, study eye

Conjunctival hyperaemia, both eyes

Visual acuity reduced, study eye

Pyrexia

Viral infection

Conjunctival disorder, both eyes

Glaucoma, both eyes

Corneal perforation, fellow eye

Acute tonsillitis

Pneumonia

Rhinitis

Epilepsy

Trabeculectomy, both eyes

Angle closure glaucoma, both eyes

Bronchitis

Developmental glaucoma, both eyes

Eye haemorrhage, study eye

100%

80%

60%

40%

20%

Study treatment Arm

Timolol

Latanoprost

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~2120

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for foot ulcers include debridement, infection control, and advanced wound care therapies such as dressings and skin substitutes. Debridement removes dead tissue to promote healing, while infection control prevents bacterial growth that can impede recovery. Advanced wound care therapies provide a conducive environment for tissue regeneration. Timolol, a beta-adrenergic receptor blocker, is being studied for its potential to promote wound healing by enhancing blood flow and reducing inflammation at the ulcer site. This is significant for foot ulcer patients as improved blood flow and reduced inflammation can accelerate healing and reduce the risk of complications such as infections and amputations.

Prostanoids in patients with peripheral arterial disease: A meta-analysis of placebo-controlled randomized clinical trials.