Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07384767
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subject of any race 18 years old or older
2. Patient opt to heal by secondary intention healing after discussion of reconstructive options following excision
3. Patients undergoing Mohs micrographic surgery, standard surgical excision, or electrodesiccation and curettage (ED\&C) whose wounds are managed by secondary intention healing.
4. Willing to send photos of ulcer at 3 week intervals with ruler measuring length by width
5. Able to give informed consent themselves
Exclusion Criteria:
1. Cyst excisions (due to concern for inflammation)
2. Site shows evidence of infection (defined as a moderate or severe rating of all of the following clinical signs/symptoms: 1) increased warmth, 2) increased pain, 3) erythema, and 4) malodorous exudate at Screening or at Randomization (Visit 1), OR total organism count \> 1 x 105 colony forming units (CFU) from the screening visit study ulcer culture sample)
3. Severe COPD/asthma/cardiac arrhythmia
4. Hx of documented beta blocker allergy
5. Cognitive impairment
6. Has medically documented history of Human Immunodeficiency Virus (HIV)
7. Has active malignancy on the study limb
8. Has immunodeficiency as defined by serum IgG, IgA, and IgM less than one-half the lower limit of normal
9. Has severe protein malnutrition as defined by serum albumin \< 2.5 g/dL
10. Has serum aspartate aminotransferase (AST, SGOT, GOT) or serum alanine aminotransferase (ALT, SGPT, GPT) levels greater than twice the upper limit of normal
11. Has fatigue, palpitations, dyspnea, and/or angina at rest
12. Has a medically documented or self-reported history, within the previous 12 months from date of Screening Visit, of alcohol or drug abuse, particularly methadone or heroin
13. Has received previous treatment with the following during the 60 days prior to Screening: Immunosuppressive agents, radiation, chemotherapy, growth factors (epidermal growth factor, tumor necrosis factor, transforming growth factor, platelet derived growth factor, etc.)
14. Has received previous treatment with the following during the 30 days prior to screening: the site of the study ulcer, split- or full-thickness skin graft at the site of the study ulcer, biologically-active (or engineered) cellular or acellular product(s) at the site of the study ulcer, investigational drug or device
15. Has history of bradycardia (heart rate less than 60)
16. Has ESR\>70mm/hr and CRP\>100 mg/L at time of screening
17. Has medically documented history of hypotension/orthostatic hypotension and/or symptomatic hypotension (systolic blood pressure below 90 and diastolic blood pressure less than 60). (Note: There is no standard testing regimen protocol for orthostatic hypotension, even for patients starting on oral timolol)
18. Currently taking asthma or COPD medications (as documented in chart)
19. Has a medically documented diagnosis of myasthenia gravis, untreated hyperthyroidism, , Type 2, Type 3 heart block, cardiogenic shock, overt cardiac failure
20. Female who is pregnant or refuses to use adequate contraceptive methods and is of childbearing age during the trial
21. Prisoners, institutionalized individuals or vulnerable population
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07384767
Study Brief:
Protocol Section:
NCT07384767