Beta Adrenergic Antagonist for the Healing of Chronic DFU — BAART-DFU  

Chronic Diabetic Foot Ulcers Clinical Trial

Official title: Beta Adrenergic Antagonist For The Healing of Chronic Diabetic Foot Ulcers

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03282981
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Completed
• Phase: Phase 3
• Start date: June 14, 2018
• Completion date: April 30, 2024