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Beta Adrenergic Antagonist for the Healing of Chronic DFU

NCT03282981 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-05-08

Study results available
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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).

Conditions

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

Interventions

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

Sponsors & Collaborators

  • VA Northern California Health Care System

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Sara E. Dahle, DPM MPH · VA Northern California Health Care System, Mather, CA

  • Rivkah R. Isseroff, MD · VA Northern California Health Care System, Mather, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2023-12-01
Completion
2024-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03282981 on ClinicalTrials.gov