Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06941467
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Timolol Maleate Solution — DRUG
    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.
  • Standard of Care — OTHER
    Vaseline

Study Details

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

Key Dates

Start date
Jan 3, 2025
Status verified
Apr 2025
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Timolol
    Participants in the topical timolol group will be instructed to apply 1-3 drops of topical 0.5% timolol solution daily to the wound.
  • Active Comparator: Standard of Care
    Standard of Care - Apply Vaseline and Band-Aid to wound bed daily

Primary Outcome Measure

Wound surface area healing (skin reepithelialization) [ Time Frame: 2 weeks, 4 weeks, 6 weeks, 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount SinaiNew YorkNew York10028
Jesse Lewin, MD
[email protected]
212-731-3316
Jaclyn Himeles, MD
[email protected]
212-731-3316
Jesse Lewin, MD (PRINCIPAL_INVESTIGATOR)

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Mount Sinai· New York, NY

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