NCT04505670

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

August 30, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

2.9 years

First QC Date

March 5, 2020

Last Update Submit

May 19, 2023

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (2)

  • Change in depth wound

    Wound will be measured in centimeters and assessed for change.

    2-4 weeks

  • Change in diameter of the wound

    Wound will be measured in centimeters and assessed for change.

    2-4 weeks

Study Arms (2)

Donepezil and Topical Zinc Oxide

EXPERIMENTAL

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

Drug: DonepezilDrug: Topical Zinc Oxide

Placebo and Topical Zinc Oxide

PLACEBO COMPARATOR

Placebo daily and topical zinc oxide 20% three times daily

Drug: Placebo oral tabletDrug: Topical Zinc Oxide

Interventions

DonepezilDRUG

donepezil orally 5mg

Donepezil and Topical Zinc Oxide
Placebo oral tabletDRUG

Placebo

Placebo and Topical Zinc Oxide
Topical Zinc OxideDRUG

Topical Zinc Oxide 20%

Donepezil and Topical Zinc OxidePlacebo and Topical Zinc Oxide

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over the age of 20
  • diagnosed with Diabetes Mellitus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Shore Medical Center at Easton

Easton, Maryland, 21601, United States

RECRUITING

MeSH Terms

Interventions

DonepezilZinc Oxide

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsOxidesOxygen CompoundsInorganic ChemicalsZinc Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2020

First Posted

August 10, 2020

Study Start

August 30, 2020

Primary Completion

July 30, 2023

Study Completion

July 30, 2023

Last Updated

May 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)