Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds

Phase 1

Recruiting

• Conditions: Wound Healing; Mohs Micrographic Surgery
• Interventions: Drug: Timolol Maleate Solution; Other: Standard of Care

• Registration Number: NCT06941467
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-03
• Status Verified: 2025-04
• Study First Submitted: 2025-04-16
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Study First Posted: 2025-04-23
• Last Update Posted: 2025-04-23
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Be scheduled to undergo MMS at 234 East 85th St for a skin cancer that is deemed Mohs
• Appropriate by the Mohs surgery appropriate use criteria
• Have an open surgical wound < 4 cm and > 0.5 cm
• Be ≥18 years of age
• English-speaking
• Provide a signed and dated informed consent form
• State willingness to comply with all study procedures

Exclusion Criteria

• Age less than 18 years of age
• Open surgical wound > 4 cm
• If tumor clearance cannot be achieved with MMS
• Pregnant women
• Breastfeeding women
• Patients who are taking oral beta-blockers (ie oral timolol, metoprolol, carvedilol, propranolol, atenolol)
• Patients who are currently taking any of the following medications: clonidine, digoxin, methyldopa, quinidine, fluoxetine and paroxetine, bupropion
• Patient currently taking a calcium channel blocker AND has pre-existing heart failure as defined by a reduced ejection fraction
• Patients with pre-existing hypotension
• Pre-existing diagnosis of sinus bradycardia
• Pre-existing diagnosis of second or third degree atrioventricular block
• Congestive heart failure
• Pre-existing diagnosis of severe asthma
• Pre-existing diagnosis of chronic obstructive pulmonary disease
• Any known hypersensitivity to 0.5% timolol solution
• Patients who have a wound where primary closure is feasible and desired by the patient
• Defect size <0.5 cm
• Prior sensitivity or known allergy to timolol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Timolol	Timolol Maleate Solution	Participants in the topical timolol group will be instructed to apply 1-3 drops of topical 0.5% timolol solution daily to the wound.
Standard of Care	Standard of Care	Standard of Care - Apply Vaseline and Band-Aid to wound bed daily

Primary Outcome Measures

Name	Time	Method
Wound surface area healing (skin reepithelialization)	2 weeks, 4 weeks, 6 weeks, 12 weeks	The wound surface area healing (skin reepithelialization) in open post-surgical lower extremity wounds will be measured using a ruler.

Secondary Outcome Measures

Name	Time	Method
Percentage change in surgical wound size	2 weeks, 4 weeks, 6 weeks, 12 weeks	Percentage change in surgical wound size
Modified Manchester Scar Scale (MMSS)	2 weeks, 4 weeks, 6 weeks, 12 weeks	The Modified Manchester Scar Scale (MMSS) is a clinical tool used to evaluate the appearance and characteristics of scars. The MMSS assess four key aspects of the scar: * Color (compared to surrounding skin): Rated 1-4; * Perfect match (1) to gross mismatch (4); * Matte vs. Shine: Rated 1-2; * Matte appearance (1); * Shiny appearance (2); * Contour: Rated 1-3; * Flush with surrounding skin (1); * Slightly proud/indented (2); * Hypertrophic (3); * Distortion: Rated 1-4; * No distortion (1 point) to severe distortion (4 points); The total score ranges from 4 to 13, with higher scores indicating a more noticeable or problematic scar.
The Pain, Enjoyment of Life and General Activity scale (PEG)	2 weeks, 4 weeks, 6 weeks, 12 weeks	The PEG, a Three-item Scale Assessing Pain Intensity and Interference Pain is is a 3-item questionnaire that measures pain intensity and pain-related functional interference with open wounds on the lower leg. The assessment includes three domains: average pain intensity (0-10), pain interference with enjoyment of life (0-10), and pain interference with general activity (0-10). The total score ranges from 0-30, with higher scores indicating greater pain intensity and greater pain-related functional interference.
Wound Quality of Life Questionnaire (Wound-QOL)	2 weeks, 4 weeks, 6 weeks, 12 weeks	The Wound-QoL is a17-item questionnaire assesses how patients feel about their open wound its impact on their quality of life. The assessment evaluates multiple dimensions of wound-related quality of life, including physical symptoms (items 1-3), functional limitations (items 4, 11-15), psychological well-being (items 6-10), and burden of care (items 5, 16-17). Each item is scored on a 5-point scale from "Not at all" (0) to "Very much" (4). The total score ranges from 0-68, with higher scores indicating lower wound quality of life.

Trial Locations

Locations (1)

Mount Sinai; 🇺🇸 New York, New York, United States