RECRUITING

Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-01-03
Study Completion:2026-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06941467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be scheduled to undergo MMS at 234 East 85th St for a skin cancer that is deemed Mohs
  2. * Appropriate by the Mohs surgery appropriate use criteria
  3. * Have an open surgical wound \< 4 cm and \> 0.5 cm
  4. * Be ≥18 years of age
  5. * English-speaking
  6. * Provide a signed and dated informed consent form
  7. * State willingness to comply with all study procedures
  1. * Age less than 18 years of age
  2. * Open surgical wound \> 4 cm
  3. * If tumor clearance cannot be achieved with MMS
  4. * Pregnant women
  5. * Breastfeeding women
  6. * Patients who are taking oral beta-blockers (ie oral timolol, metoprolol, carvedilol, propranolol, atenolol)
  7. * Patients who are currently taking any of the following medications: clonidine, digoxin, methyldopa, quinidine, fluoxetine and paroxetine, bupropion
  8. * Patient currently taking a calcium channel blocker AND has pre-existing heart failure as defined by a reduced ejection fraction
  9. * Patients with pre-existing hypotension
  10. * Pre-existing diagnosis of sinus bradycardia
  11. * Pre-existing diagnosis of second or third degree atrioventricular block
  12. * Congestive heart failure
  13. * Pre-existing diagnosis of severe asthma
  14. * Pre-existing diagnosis of chronic obstructive pulmonary disease
  15. * Any known hypersensitivity to 0.5% timolol solution
  16. * Patients who have a wound where primary closure is feasible and desired by the patient
  17. * Defect size \<0.5 cm
  18. * Prior sensitivity or known allergy to timolol

Contacts and Locations

Study Contact

Jesse Lewin, MD
CONTACT
212-731-3316
jesse.lewin@mountsinai.org
Jaclyn Himeles, MD
CONTACT
212-731-3316
jaclyn.himeles@mountsinai.org

Principal Investigator

Jesse Lewin, MD
PRINCIPAL_INVESTIGATOR
Primary Investigator

Study Locations (Sites)

Mount Sinai
New York, New York, 10028
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Jesse Lewin, MD, PRINCIPAL_INVESTIGATOR, Primary Investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-03
Study Completion Date2026-04-01

Study Record Updates

Study Start Date2025-01-03
Study Completion Date2026-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Wound Healing
  • Mohs Micrographic Surgery