Recruiting
Phase 2

Donepezil

Sponsor:

University of Maryland, Baltimore

Code:

NCT04505670

Conditions

Wound Heal

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Interventions

Donepezil

Placebo oral tablet

Topical Zinc Oxide

Study Details

Brief summary:

The purpose of the study is to test effectiveness of donepezil to improve wound healing in patients with diabetic wounds that have not healed with standard treatment.

Conditions

Wound Heal

Study ID

NCT04505670

Start date

Aug 30, 2020

Status verified date

May, 2023

Completion date

Jul 30, 2023

Anticipated

Primary completion date

Jul 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • over the age of 20
  • diagnosed with Diabetes Mellitus

Exclusion Criteria:

  • under the age of 20
  • pregnant of lactating
  • lactose intolerance
  • allergy to donepezil
  • prothrombin time and international normalized ratio value greater than 1.25
  • Pre Menopausal women/ Women of childbearing potential

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Donepezil and Topical Zinc Oxide

donepezil 5mg daily and topical zinc oxide 20% three times daily

placebo comparator: Placebo and Topical Zinc Oxide

Placebo daily and topical zinc oxide 20% three times daily

Interventions

Donepezil

donepezil orally 5mg

Placebo oral tablet

Placebo

Topical Zinc Oxide

Topical Zinc Oxide 20%

Primary outcome measure

  • Change in depth wound [ Time Frame: 2-4 weeks ]
  • Change in diameter of the wound [ Time Frame: 2-4 weeks ]

Central Contacts and Locations

Locations

University of Maryland Shore Medical Center at Easton

Recruiting

Easton, Maryland, United States, 21601

Contacts

Stephen Wills, MD

410-822-1000swills@umm.edu

Principal Investigator:

Stephen Wills, MD

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

May 22, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2023-05-22.