Pressure UlcerNCT04634838
Efficacy of Wound Dressings With Copper Oxide
A study testing MedCu Antibacterial Wound Dressings with Copper Oxide in people with Pressure Ulcer and Diabetic Foot Ulcer, run by MedCu Technologies Ltd. at 1 site in Israel.
Trial summary
Thirty patients of 18-85 years of age, with 2-30 cm2 pressure ulcers or post-op wounds, will be recruited and treated with either wound dressing containing silver or wound dressings containing copper oxide microparticles. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pressure Ulcer, Diabetic Foot Ulcer
- What is being tested?
- MedCu Antibacterial Wound Dressings with Copper Oxide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Feb 2021to 30 Apr 2023
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Wound size 2-30 cm2.
- Non-infected wounds.
- Having at least moderate blood perfusion into the affected limb as defined by palpable pulses (Dorsalis Pedis and/or Tibialis Posterior, unequivocally palpable). If no pulse is clearly present in vascular lab tests Ankle Brachial Index (ABI) should be 0.6< or if ABI > 1.3, then toe pressure of > 50 mmHg.
- Having a body mass index (BMI) <40 Kg/m2.
- Glycosylated haemoglobin (HbA1c) <12.0%.
- Not undergoing any systemic or topical antibiotic treatment for the wound for a week before enrollment in the study.
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- The patient is able and eligible to sign written informed consent and participate in the study.
- Be available for the entire study period, and ability and willingness to adhere to the requirements of the study.
- In case of post-op wounds, at least three weeks post-op, wounds that do not show significant healing (reduction of wound size of less than 50% in 3 weeks)
Who cannot join
- A clinically significant active or unstable cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease.
- Psychiatric condition.
- Active participation in an investigational trial within 30 days of the screening visit.
- History of allergic reactions attributed to copper.
- Patient with known allergy to at least thee drugs or other substances.
- Any chronic or acute condition susceptible of interfering with the evaluation of the wound dressing effect.
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- Individuals using and need to continue use any type of topical agents in or on the wound.
- Any form of substance abuse (including drug or alcohol abuse, excluding cannabis), psychiatric disorder or any chronic condition susceptible, in the opinion of the investigator, of interfering with the conduct of the study.
- Females who are pregnant, lactating, of child-bearing potential.
- Fertile female subjects who are not willing to use an acceptable method of contraception during the study.
- Subjects who are likely to be non-compliant or uncooperative during the study.
- Wound related parameters:
- The size of the wounds is reduced by more than 50% during the three weeks presiding the study.
- Wounds in which local pressure cannot be avoided due to protruding bone, or any other complex rehabilitation procedure.
- Wounds determined to be infected wounds.
- Wounds that are considered to necessitate debridement in the operation room during the study.
- Wounds that necessitate antibiotic treatment or needed antibiotic treatment one week prior to the trial.
- Necrotic wounds.
- Wound with tunnels of more than 3 cm.
- Lab parameters:
- Hemoglobin below 7.0 g/dl
- White blood cells count > 14,000/ul
- Albumin <2.5 g/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Efficacy Study of MedCu Wound Dressings With Copper Oxide in Treating Pressure Sores and Post-op Wounds
Thirty patients of 18-85 years of age, with 2-30 cm2 pressure ulcers or post-op wounds, will be recruited and treated with either wound dressing containing silver or wound dressings containing copper oxide microparticles. The efficacy of the two types of dressings in reducing the size and improving the condition of the wounds will be compared.
Read the detailed description
The study will be divided into 3 periods. Patients with pressure ulcers or post-operation wounds with wound areas of 2-30 cm2, who will accept participating in the study, pass all the accepted inclusion criteria, and sign the informed consent form, will be recruited. Then they will be treated with silver dressings for up to three weeks (first period). In case that the wounds will not show a reduction of at least 50% of the wound area during the first period, then the wounds will be treated with the copper oxide dressings for at least 3 weeks (second period). In case that there will be a clear improvement during the second period, the wounds may continue to be treated with the copper oxide dressings or with any other wound dressings according to the treating physician judgement and decision for an additional 3 weeks (third period) or earlier if the wound will be closed.
- Conditions
- Pressure Ulcer, Diabetic Foot Ulcer
- Being tested
- MedCu Antibacterial Wound Dressings with Copper Oxide
- Keywords
- wound dressings, copper oxide, silver, wound healing
- Medical subject headings
- Pressure Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedCu Antibacterial Wound Dressings with Copper OxideDevice
Comparison between the efficacy of antibacterial wound dressings containing copper oxide microparticles to improve the wound healing of pressure sores and post-op wounds as compared to silver wound dressings
| Study group | Role | What they receive |
|---|---|---|
| MedCu Antibacterial Wound Dressings with Copper Oxide | Other | Wound dressings impregnated with copper oxide microparticles will be applied in wounds treated with antibacterial wound dressings with silver that their sizes were not reduced by at least 50% during three weeks of treatment. Receives: Device: MedCu Antibacterial Wound Dressings with Copper Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction of wound size
The area and volume of the wounds will be measured every 7 days during the study period. The percent reduction as compared to the area and volume of the wounds at the commencement of the study and in relevance to the treatment (silver or copper oxide dressings) will be determined.
Measured: 9 weeks
Secondary outcomes (2)
Percent of granulation tissue
The percent of granulation tissue in the wounds will be measured every 7 days during the study period. The increase in the percent of granulation tissue following the silver and the copper oxide dressings treatment will be compared.
Measured: 9 weeks
Number of infectious episodes
The number of infections that may occur during the silver and copper oxide dressings treatments will be compared.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start2 Feb 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Why it stopped: In view of the very positive results obtained with the copper dressings after 20 patients, the researchers decided to apply copper dressings from the beginning of wound management, not to use anymore silver dressings and to terminate the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedCu Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634838
- Sponsor's protocol ID
- 002-20-LOE
- Status last verified
- Mar 2023
- First submitted
- 12 Nov 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Efficacy Study of MedCu Wound Dressings With Copper Oxide in Treating Pressure Sores and Post-op Wounds
- ClinicalTrials.gov ID
- NCT04634838
- Acronym / sponsor ID
- 002-20-LOE
- Conditions
- Pressure Ulcer, Diabetic Foot Ulcer
- Keywords
- wound dressings, copper oxide, silver, wound healing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In view of the very positive results obtained with the copper dressings after 20 patients, the researchers decided to apply copper dressings from the beginning of wound management, not to use anymore silver dressings and to terminate the trial.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- MedCu Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 18 Nov 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.
Thirty patients of 18-85 years of age, with 2-30 cm2 pressure ulcers or post-op wounds, will be recruited and treated with either wound dressing containing silver or wound dressings containing copper oxide microparticles. The efficacy of the two types of dressings in reducing the size and improving the condition of the wounds will be compared.
Detailed description
The study will be divided into 3 periods. Patients with pressure ulcers or post-operation wounds with wound areas of 2-30 cm2, who will accept participating in the study, pass all the accepted inclusion criteria, and sign the informed consent form, will be recruited. Then they will be treated with silver dressings for up to three weeks (first period). In case that the wounds will not show a reduction of at least 50% of the wound area during the first period, then the wounds will be treated with the copper oxide dressings for at least 3 weeks (second period). In case that there will be a clear improvement during the second period, the wounds may continue to be treated with the copper oxide dressings or with any other wound dressings according to the treating physician judgement and decision for an additional 3 weeks (third period) or earlier if the wound will be closed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MedCu Antibacterial Wound Dressings with Copper Oxide | Other | Device: MedCu Antibacterial Wound Dressings with Copper OxideWound dressings impregnated with copper oxide microparticles will be applied in wounds treated with antibacterial wound dressings with silver that their sizes were not reduced by at least 50% during three weeks of treatment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Wound size 2-30 cm2.
- Non-infected wounds.
- Having at least moderate blood perfusion into the affected limb as defined by palpable pulses (Dorsalis Pedis and/or Tibialis Posterior, unequivocally palpable). If no pulse is clearly present in vascular lab tests Ankle Brachial Index (ABI) should be 0.6< or if ABI > 1.3, then toe pressure of > 50 mmHg.
- Having a body mass index (BMI) <40 Kg/m2.
- Glycosylated haemoglobin (HbA1c) <12.0%.
Key exclusion criteria (23 listed)
- A clinically significant active or unstable cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease.
- Psychiatric condition.
- Active participation in an investigational trial within 30 days of the screening visit.
- History of allergic reactions attributed to copper.
- Patient with known allergy to at least thee drugs or other substances.
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 |
|---|---|---|
| MedCu Antibacterial Wound Dressings with Copper OxideComparison between the efficacy of antibacterial wound dressings containing copper oxide microparticles to improve the wound healing of pressure sores and post-op wounds as compared to silver wound dressings | Device | MedCu Antibacterial Wound Dressings with Copper Oxide |
Primary outcome
Percent reduction of wound size
Time frame: 9 weeks
The area and volume of the wounds will be measured every 7 days during the study period. The percent reduction as compared to the area and volume of the wounds at the commencement of the study and in relevance to the treatment (silver or copper oxide dressings) will be determined.
2 secondary outcomes
Percent of granulation tissue
Time frame: 9 weeks
Number of infectious episodes
Time frame: 9 weeks
Results and safety
The study was stopped early (reason given: In view of the very positive results obtained with the copper dressings after 20 patients, the researchers decided to apply copper dressings from the beginning of wound management, not to use anymore silver dressings and to terminate the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedCu Antibacterial Wound Dressings with Copper Oxide in people with Pressure Ulcer and Diabetic Foot Ulcer, run by MedCu Technologies Ltd. at 1 site in Israel.
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 9 inclusion and 23 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: stopped early, as of the sponsor's last update on 23 Oct 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: In view of the very positive results obtained with the copper dressings after 20 patients, the researchers decided to apply copper dressings from the beginning of wound management, not to use anymore silver dressings and to terminate the trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction of wound size (time frame: 9 weeks). 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 23 Oct 2023.