Clinical trial

The Effect of Donepezil on Wound Healing

Name

SH2019-8

Description

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.

Trial arms

Trial start

2020-08-30

Estimated PCD

2023-07-30

Trial end

2023-07-30

Status

Recruiting

Phase

Early phase I

Treatment

Donepezil

donepezil orally 5mg

Arms:

Donepezil and Topical Zinc Oxide

Placebo oral tablet

Placebo

Arms:

Placebo and Topical Zinc Oxide

Topical Zinc Oxide

Topical Zinc Oxide 20%

Arms:

Donepezil and Topical Zinc Oxide, Placebo and Topical Zinc Oxide

Size

Primary endpoint

Change in depth wound

2-4 weeks

Change in diameter of the wound

2-4 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2023-05-22

1 organization

3 products

1 indication

Organization

University of Maryland, Baltimore

Product

Indication

Product

Product