CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 48 enrolled
Drug / intervention
Timolol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03282981
NCT03282981Phase 3Completed

Beta Adrenergic Antagonist For The Healing of Chronic Diabetic Foot Ulcers

VA Office of Research and Development·interventional·Posted Sep 14, 2017·Updated May 8, 2025

In Brief

A Phase 3 clinical trial evaluating Timolol and Non biologically active gel for Chronic Diabetic Foot Ulcers and 2 related conditions. Completed, enrolled 48 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 14, 2017
Enrollment StartJul 24, 2018
Primary CompletionDec 1, 2023
Study CompletionApr 30, 2024
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 8.8 years ago

Interventions

Timololdrug

Topical application of Timolol on non-healing diabetic foot ulcers

Non biologically active geldrug

Topical application of non biologically active gel (Hydrogel- standard of care) on non-healing diabetic foot ulcers