Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds

Official title

Efficacy of Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds

Overview

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

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

Primary outcome measures

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

Secondary outcome measures (4)

• Percentage change in surgical wound size [Time frame: 2 weeks, 4 weeks, 6 weeks, 12 weeks]
• Modified Manchester Scar Scale (MMSS) [Time frame: 2 weeks, 4 weeks, 6 weeks, 12 weeks]
• The Pain, Enjoyment of Life and General Activity scale (PEG) [Time frame: 2 weeks, 4 weeks, 6 weeks, 12 weeks]
• Wound Quality of Life Questionnaire (Wound-QOL) [Time frame: 2 weeks, 4 weeks, 6 weeks, 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Mount Sinai — New York

Identifiers

NCT: NCT06941467 · STUDY-23-01193

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗