Wound HealPhase 2NCT04505670
The Effect of Donepezil on Wound Healing
A Phase 2 study testing Donepezil and Topical Zinc Oxide in people with Wound Heal, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- Donepezil and Topical Zinc Oxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2020to 30 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over the age of 20
- diagnosed with Diabetes Mellitus
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Maryland Shore Medical Center at Easton
Easton, Maryland, 21601
Stephen Wills, MD, 410-822-1000, swills@umm.edu
Stephen Wills, MD
About this study
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.
Read the detailed description
The study will be a randomized double blind study whereby patients with refractory diabetic wound healing over 3-6 months will be randomized to ascertain the effect of donepezil (administration of 5 mg to 10 mg of donepezil daily, orally, over 6 week period) on clinical wound healing reflecting correction of diabetic microvascular disease of non-healing wounds. The subjects will be recruited from the University of Maryland Shore Medical Center at Easton's emergency room and inpatients. Subjects will also be recruited from University of Maryland Shore Medical Group Wound Care and University of Maryland Baltimore Washington Medical Center's Vascular Clinic.
20 patients with Type 2 Diabetes Mellitus (Adult Onset Diabetes Mellitus) and non-healing ulcers/ wounds refractory to management with topical preparation and local debridement over a 3 to 6 month period prior will randomized to treatment or control group. The study group will be treated with oral donepezil (5 to 10 mg ). After 3 days of treatment, the dose of donepezil or placebo will be increased to 10 if no improvements are noted in skin integrity in the feet or lower extremity. Improvements in capillary refill and vascular edema will determine increase of donepezil from 5 to 10 mg. All patients will receive topical zinc oxide 20% topically three times a day, an effective topical management of diabetic wounds. Measurement of wound size and depth will be made prior to treatment. Additionally a color photograph will be obtained to compare with wound appearance in 6 weeks.
As many patients as required to meet the enrollment numbers shall be screened. Patients will be monitored daily for blood pressure, glucose levels and heart rate, during the period of hospitalization. Adjustments in insulin or oral hypoglycemic, blood pressure and heart rate control medications will occur during this time. Follow up visits will be made as required and at the end of week 6.
Donepezil shall be orally administered to the study group. Control group will get an orally administered placebo which is an inert compound, lactulose.
Wk0 will be the randomization visit. The patients will take the drug for 6 weeks and the last follow up visit will be the last day of week 6. Follow up at 6 weeks will occur at Shore Rehab at Easton.
Any anticholinergic drugs will be eliminated from the patients' medical regimen with the exception for inhaled anticholinergic. There is no known major contraindication of acetylcholinesterase inhibitors (like for eg: galantamine, rivastigmine and donepezil) Patients shall be monitored closely for vagotonic effect. Acetylcholine is known to have a vagotonic effect lowering heart rate and blood pressure. Therefore, during the course of administration of the drug close attention to heart rate and blood pressure will be a significant part off the clinical management of patients. If the patients are on beta blockers, their beta blocker dose will be closely monitored and adjusted as required.
H2 antagonist will be used to guard against any possible GI bleed, Pepcid 20mg a day.
Patient will be observed for seizures. The patients will be examined for pulmonary exacerbation during treatment in the hospital. If the pulmonary status deteriorates they will be eliminated from the study. The medication administration will not start sooner than 24 hrs after surgery. Patients shall be observed for exaggerated response from anesthesia.
Photographs of the diabetic wound/ ulcer and HgbA1C will be obtained on introduction to study and obtained at completion at 6 weeks.
- Conditions
- Wound Heal
- Being tested
- Donepezil, Placebo oral tablet, Topical Zinc Oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
donepezil orally 5mg
Placebo oral tabletDrug
Placebo
Topical Zinc OxideDrug
Topical Zinc Oxide 20%
| Study group | Role | What they receive |
|---|---|---|
| Donepezil and Topical Zinc Oxide | Experimental | donepezil 5mg daily and topical zinc oxide 20% three times daily Receives: Drug: Donepezil; Drug: Topical Zinc Oxide |
| Placebo and Topical Zinc Oxide | Placebo comparator | Placebo daily and topical zinc oxide 20% three times daily Receives: Drug: Placebo oral tablet; Drug: Topical Zinc Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depth wound
Wound will be measured in centimeters and assessed for change.
Measured: 2-4 weeks
Change in diameter of the wound
Wound will be measured in centimeters and assessed for change.
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start30 Aug 2020
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Wills, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505670
- Sponsor's protocol ID
- SH2019-8
- Status last verified
- May 2023
- First submitted
- 5 Mar 2020
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Donepezil on Wound Healing
- ClinicalTrials.gov ID
- NCT04505670
- Acronym / sponsor ID
- SH2019-8
- Conditions
- Wound Heal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be a randomized double blind study whereby patients with refractory diabetic wound healing over 3-6 months will be randomized to ascertain the effect of donepezil (administration of 5 mg to 10 mg of donepezil daily, orally, over 6 week period) on clinical wound healing reflecting correction of diabetic microvascular disease of non-healing wounds. The subjects will be recruited from the University of Maryland Shore Medical Center at Easton's emergency room and inpatients. Subjects will also be recruited from University of Maryland Shore Medical Group Wound Care and University of Maryland Baltimore Washington Medical Center's Vascular Clinic.
20 patients with Type 2 Diabetes Mellitus (Adult Onset Diabetes Mellitus) and non-healing ulcers/ wounds refractory to management with topical preparation and local debridement over a 3 to 6 month period prior will randomized to treatment or control group. The study group will be treated with oral donepezil (5 to 10 mg ). After 3 days of treatment, the dose of donepezil or placebo will be increased to 10 if no improvements are noted in skin integrity in the feet or lower extremity. Improvements in capillary refill and vascular edema will determine increase of donepezil from 5 to 10 mg. All patients will receive topical zinc oxide 20% topically three times a day, an effective topical management of diabetic wounds. Measurement of wound size and depth will be made prior to treatment. Additionally a color photograph will be obtained to compare with wound appearance in 6 weeks.
As many patients as required to meet the enrollment numbers shall be screened. Patients will be monitored daily for blood pressure, glucose levels and heart rate, during the period of hospitalization. Adjustments in insulin or oral hypoglycemic, blood pressure and heart rate control medications will occur during this time. Follow up visits will be made as required and at the end of week 6.
Donepezil shall be orally administered to the study group. Control group will get an orally administered placebo which is an inert compound, lactulose.
Wk0 will be the randomization visit. The patients will take the drug for 6 weeks and the last follow up visit will be the last day of week 6. Follow up at 6 weeks will occur at Shore Rehab at Easton.
Any anticholinergic drugs will be eliminated from the patients' medical regimen with the exception for inhaled anticholinergic. There is no known major contraindication of acetylcholinesterase inhibitors (like for eg: galantamine, rivastigmine and donepezil) Patients shall be monitored closely for vagotonic effect. Acetylcholine is known to have a vagotonic effect lowering heart rate and blood pressure. Therefore, during the course of administration of the drug close attention to heart rate and blood pressure will be a significant part off the clinical management of patients. If the patients are on beta blockers, their beta blocker dose will be closely monitored and adjusted as required.
H2 antagonist will be used to guard against any possible GI bleed, Pepcid 20mg a day.
Patient will be observed for seizures. The patients will be examined for pulmonary exacerbation during treatment in the hospital. If the pulmonary status deteriorates they will be eliminated from the study. The medication administration will not start sooner than 24 hrs after surgery. Patients shall be observed for exaggerated response from anesthesia.
Photographs of the diabetic wound/ ulcer and HgbA1C will be obtained on introduction to study and obtained at completion at 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donepezil and Topical Zinc Oxide | Experimental | Drug: Donepezil, Drug: Topical Zinc Oxidedonepezil 5mg daily and topical zinc oxide 20% three times daily |
| Placebo and Topical Zinc Oxide | Placebo comparator | Drug: Placebo oral tablet, Drug: Topical Zinc OxidePlacebo daily and topical zinc oxide 20% three times daily |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over the age of 20
- diagnosed with Diabetes Mellitus
Key exclusion criteria (6 listed)
- under the age of 20
- pregnant of lactating
- lactose intolerance
- allergy to donepezil
- prothrombin time and international normalized ratio value greater than 1.25
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezildonepezil orally 5mg | Drug | Donepezil and Topical Zinc Oxide |
| Placebo oral tabletPlacebo | Drug | Placebo and Topical Zinc Oxide |
| Topical Zinc OxideTopical Zinc Oxide 20% | Drug | Donepezil and Topical Zinc Oxide, Placebo and Topical Zinc Oxide |
Primary outcome
Change in depth wound
Time frame: 2-4 weeks
Wound will be measured in centimeters and assessed for change.
Change in diameter of the wound
Time frame: 2-4 weeks
Wound will be measured in centimeters and assessed for change.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University of Maryland Shore Medical Center at Easton
Easton, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donepezil and Topical Zinc Oxide in people with Wound Heal, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depth wound (time frame: 2-4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.