NCT03282981

Beta Adrenergic Antagonist for the Healing of Chronic DFU

Beta Adrenergic Antagonist For The Healing of Chronic Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

One in four Veterans is affected by diabetes and will develop a diabetic foot ulcer. Diabetic ulcers are very challenging to manage and are the most common cause of leg amputation. Many advanced treatments are expensive and difficult to use in the clinic or at home. Those newer therapies have shown little success in healing diabetic foot wounds. The investigators' laboratory and animal work has suggested that a safe medication, currently used as an eye drop for treatment of glaucoma, can heal these ulcers. The investigators are proposing to test this drop (timolol) directly on the surface of the foot ulcer to see if can improve healing faster than the current standard of care. To do this, the investigators propose a "randomized controlled trial" with two groups of patients with diabetic foot ulcers: one will receive standard of care with timolol while the other will receive standard of care with a gel (hydrogel, as placebo medicine).

Detailed description

The trial is designed as a prospective, randomized, double-blinded controlled study of subjects presenting with diabetic foot ulcers. The purpose of this study is to evaluate the superiority of Timoptic-XE therapy in conjunction with standard of care (SOC) treatment (Group A: Timoptic-XE + SOC) versus SOC (Group B: SOC + plus a non-biologically active gel, i.e., hydrogel, as placebo medication) in the clinical effectiveness in promoting wound healing and closure.

Conditions

• Chronic Diabetic Foot Ulcers
• Diabetic Neuropathic Ulcers
• Non Healing Wound

Interventions

Type	Name	Description
DRUG	Timolol	Topical application of Timolol on non-healing diabetic foot ulcers
DRUG	Non biologically active gel	Topical application of non biologically active gel (Hydrogel- standard of care) on non-healing diabetic foot ulcers

Timeline

• Start date: 2018-07-24
• Primary completion: 2023-12-01
• Completion: 2024-04-30
• First posted: 2017-09-14
• Last updated: 2025-05-08
• Results posted: 2025-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study