Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds
NCT06941467 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2025-04-23
Summary
Topical timolol, a β2-Adrenergic receptor (B2AR) antagonist, has demonstrated promise in wound healing over the past several years. The majority of the literature has evaluated the use of topical timolol to shorten wound healing time in chronic wounds of non-surgical etiologies. To date, there are no prospective randomized clinical trials evaluating the role of topical timolol for shortening wound healing time in acute open surgical wounds.
Therefore, the purpose of this study is to determine whether or not topical timolol solution decreases time to wound healing in patients with defects after Mohs Micrographic Surgery (MMS) that cannot be closed with sutures and are left to heal by second intent. The research team also will look to determine if there is a difference in cosmesis of wounds treated with topical timolol compared to those treated with the standard of care. The present study will primarily focus on wounds in the distal lower extremity as these are most commonly left to heal by secondary intent
Conditions
- Wound Healing
- Mohs Micrographic Surgery
Interventions
- DRUG
-
Timolol Maleate Solution
Timolol 0.5% solution. The number of drops delivered will be based on the initial wound size and will remain constant for the duration of the study period or until the wound is fully re-epithelialized which will be determined by the PI either by photo or in person visit.
- OTHER
-
Standard of Care
Vaseline
Sponsors & Collaborators
-
Icahn School of Medicine at Mount Sinai
lead OTHER
Principal Investigators
-
Jesse Lewin, MD · Primary Investigator
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-03
- Primary Completion
- 2026-04-01
- Completion
- 2026-04-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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