Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age less than 18 years of age
Open surgical wound > 4 cm
If tumor clearance cannot be achieved with MMS
Pregnant women
Trial design
Design model
Single group
Treatments tested in this trial
Timolol Maleate Solution
DrugTimolol 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 interventionVaseline
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: TimololExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Wound surface area healing (skin reepithelialization)
The wound surface area healing (skin reepithelialization) in open post-surgical lower extremity wounds will be measured using a ruler.
Time frame
2 weeks, 4 weeks, 6 weeks, 12 weeksSecondary outcomes
1
Percentage change in surgical wound size
Percentage change in surgical wound size
Time frame
2 weeks, 4 weeks, 6 weeks, 12 weeks2
Modified Manchester Scar Scale (MMSS)
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.
Time frame
2 weeks, 4 weeks, 6 weeks, 12 weeks3
The Pain, Enjoyment of Life and General Activity scale (PEG)
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.
Time frame
2 weeks, 4 weeks, 6 weeks, 12 weeks4
Wound Quality of Life Questionnaire (Wound-QOL)
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.
Time frame
2 weeks, 4 weeks, 6 weeks, 12 weeksSponsors and contacts
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Source ClinicalTrials.gov