Wounds and InjuriesNCT05215730
Comparison of Wound Healing Between MedCu Dressings With Copper Oxide and Negative Pressure Wound Therapy Treatment
A study testing MedCu wound dressings with copper oxide (COD) in people with Wounds and Injuries and Negative Pressure Therapy, run by MedCu Technologies Ltd. at 1 site in Israel.
Trial summary
Randomized multisite two arms study in which one arm of patients will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm") and the second arm of patients will be treated with MedCu wound dressings with copper oxide (COD) ("Copper Arm"). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Wounds and Injuries, Negative Pressure Therapy, Diabetic Foot Ulcer
- What is being tested?
- MedCu wound dressings with copper oxide (COD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- 7 Jul 2021to 10 Oct 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
- Male or female subjects, 18 to 85 years of age at the time of enrollment.
- Subject has Diabetes Mellitus (type 1 or type 2) by WHO criteria.
- Wounds in which a decision to treat it with Negative Pressure Wound Therapy (NPWT) has been made due to the wound condition and the physician practice (the wound should be one that deem suitable to NPWT treatment).
- In the case of wounds involving the plantar aspects, they should be without significant bony prominences (unless off-loading can effectively relieve these pressure areas).
- The wound does not have overt signs of infection or if there is residual infection, it is under control and in the process of resolving as evidenced by laboratory tests (within one day prior to study commencement for in-house patients) and clinical judgment.
- The wound type configuration and location clearly allows the application of VAC with efficient sealing.
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- If there are additional wounds in the same foot that can be connected by the same VAC apparatus, then each wound will be considered as an index wound and analyzed separately. If there are additional wounds that cannot be connected by the VAC apparatus, the criteria to include the patient in the study is that these wounds can be dressed separately and not interfere with the VAC apparatus. These wounds will be treated by SOC and will not be included in the statistical analysis.
- Vascular assessment:
- All patients need to have ankle-brachia index (ABI) determination even in the presence of palpable pulses. If ABI is > 0.5 in both arteries, or >0.8 in at least one artery, the patient will be eligible to participate in the study.
- Patients in whom reliable ABI cannot be obtain due to non-compressible arteries, toe-brachial index (TBI) will be assessed and it needs to be > 40.
- Patients who have undergone successful vascular intervention will be assessed by ABI measurements. Nevertheless, if in such patients the value will negate participation in the study, vascular surgeon consultation or interventional radiologist report on good outcome during the procedure will allow inclusion in the study.
- Having a body mass index (BMI) <45 Kg/m2.
- Recent glycosylated haemoglobin (HbA1c) <12.0%.
- Recent creatinine level ≤3.0 mg/dL.
- No further surgery to handle the wound or the infection is expected or contemplated.
- 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.
Who cannot join
- General conditions:
- Unstable cardiac disease or other medical conditions with expected repeated hospitalizations during the study phase.
- Participation in an investigational trial (active phase) at the time of study inclusion.
- History of allergic reactions attributed to copper; Wilson disease.
- Any patients receiving or expected to receive chemotherapy during the study period.
- 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.
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- 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 treatment period and for 14 days following completion of treatment.
- Subjects who are likely to be non-compliant or uncooperative during the study.
- Subjects and conditions in which a non-approval of VAC therapy (usually be the HMO) is expected or suspected.
- Laboratory tests:
- Anemia (Hemoglobin < 7.0 g/dL).
- BMI > 45 Kg/m2.
- White Blood Cells count > 12,000/μL (higher levels are affordable if clinical improvement and other laboratory signs of improvement are evident).
- Platelet's count < 75,000/μL.
- Albumin < 2.0 g/dL.
- CRP - may be higher than normal but should be stable at the time of enrollment or a with a trend toward improvement.
- Blood Creatinine > 3.0 mg/dL at the time of enrolment.
- Any other clinically significant blood and urinalysis tests abnormalities that can jeopardize study results as evaluated by the investigator.
- Wound condition:
- Any signs of active or residual infection of the wound that need close inspection and/or repeated debridement.
- Wounds that deem unsuitable to NPWT treatment due to expected problem of sealing the wound (e.g. wound with toe clefts) or too painful to handle such treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Wound Healing Efficacy Between MedCu Wound Dressings With Copper Oxide and Negative Pressure Wound Therapy (NPWT/VAC) Treatment
Randomized multisite two arms study in which one arm of patients will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm") and the second arm of patients will be treated with MedCu wound dressings with copper oxide (COD) ("Copper Arm"). The study goals are to compare the efficacy, cost and convenience between MedCu Wound Dressings with Copper Oxide (COD) and Negative Pressure Wound Therapy of diabetic foot wounds.
Read the detailed description
Randomized multisite two arms study: one arm will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm"). The second arm with MedCu wound dressings with copper oxide (COD) ("Copper Arm").
Prior to the commencement of the study the patients will be treated according to the caregiver routine and the wound and patient condition, e.g. surgical or bedside debridement, minor foot amputation and/or various wound dressings. Patients whose foot condition has improved and there is indication for VAC treatment will be randomized to either treatment arm after signing informed consent.
The patients will be then treated for 2-8 weeks with the study treatment.
Treatment termination - Treatment will be stopped due to the following reasons:
- Treatment failure
- Wound deterioration
- Wound infection
- Adverse events
- Inability to continue the current treatment for any other reason unrelated to the treatment modality
- Expected termination (two to eight weeks) - no indication to continue treatment arm or if sufficient granulation has been achieved and the patient is candidate for skin grafting
- Wound closure The VAC treatment will be performed twice weekly, according to the routine practice (usually 75-150 mm Hg). The COD will be changed once a week or more often in highly exudating wounds. The patients will be monitored at least every two weeks in the clinic, but documentation of the wound condition will be obtained in every dressing change or VAC replacement.
Follow-up Period - Patients will be monitored for two additional weekly or biweekly visits (total of 2-4 weeks). The Follow-up Period will be following treatment termination (including wound closure).
In the follow-up period the patient will be treated according to the physician decision based on standard of care, available treatment and wound condition. Continue treatment with the same arm modality, for which the patient had been randomized is allowed and will be recorded. Change into the other arm treatment will be allowed but will be documented as a "Cross Over" and the reason for the cross over will be stated.
- Being tested
- MedCu wound dressings with copper oxide (COD)
- Keywords
- wound dressings, copper oxide, diabetic ulcers, Negative pressure wound therapy
- Medical subject headings
- Wounds and Injuries, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedCu wound dressings with copper oxide (COD)Device
Also called Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment
Patients whose foot wound is indicated for VAC treatment will be randomized to either treatment arm after signing informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Copper oxide dressings (COD) | Active comparator | MedCu wound dressings with copper oxide (COD) ("Copper Arm"). Receives: Device: MedCu wound dressings with copper oxide (COD) |
| Vacuum-assisted closure (VAC) treatment ("VAC Arm") | Active comparator | Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm"). Receives: Device: MedCu wound dressings with copper oxide (COD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound size
The size of the wound will be determined by using a 3D Wound Imaging System
Measured: 4, 8 and 12 weeks of treatment
Secondary outcomes (11)
Physiological parameter - Change in granulation tissue
Percentage of granulation tissue will be determined based on the physicians evaluation and by Tissue Analytics Imaging system
Measured: 4, 8 and 12 weeks of treatment
Physiological parameter - Percentage of wounds that will be closed during the study period
The percent of closed wounds per study group will be calculated and compared
Measured: 12 weeks
Cost of treatment
The mean cost of treatment per patient in each of the two study groups will be calculated. It will include cost of the actual equipment (dressings versus VAC) and time of treatment by caregivers.
Measured: 12 weeks
Convenience - patient perspective - Questionnaire
The patients will be asked to give an indication of their convenience perspective of the treatment by giving a grade between 1-10, being 1 "not convenient at all" and 10 "very convenient".
Measured: 12 weeks
Convenience - caregiver perspective - Questionnaire
The caregivers will be asked to give an indication of their convenience perspective of the treatment by giving a grade between 1-10, being 1 "not convenient at all" and 10 "very convenient".
Measured: 12 weeks
Pain - patients perspective - Questionnaire
The patients will be asked to give an indication of the pain they felt during treatment by giving a grade between 1-10, being 1 "felt no pain" and 10 "felt extreme pain".
Measured: 12 weeks
Physiological parameter - Infectious episodes
The number of infectious episodes, which will include fever, antibiotic administration, and wound infection, during the trial will be recorded and compared between both study arms.
Measured: 12 weeks
Physiological parameter - Number of treatment-related adverse events as assessed by CTCAE v4.0
The number of treatment-related adverse event episodes during the trial will be assessed in both study arms according to CTCAE v4.0
Measured: 12 weeks
Physiological parameter - Change in necrotic tissue
Percentage of necrotic tissue will be determined based on the physicians evaluation and by Tissue Analytics Imaging system
Measured: 4, 8 and 12 weeks of treatment
Physiological parameter - Change in fibrin tissue
Percentage of fibrin tissue will be determined based on the physicians evaluation and by Tissue Analytics Imaging system
Measured: 4, 8 and 12 weeks of treatment
Physiological parameter - Average time to wound closure
The average time to close the wounds in each arm will be determined
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start7 Jul 2021
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized multisite two arms study: one arm will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm"). The second arm with MedCu wound dressings with copper oxide (COD) ("Copper Arm").
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedCu Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eyal Melamed, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215730
- Sponsor's protocol ID
- WD-2C-1012-02-IL
- Status last verified
- Oct 2023
- First submitted
- 3 Jan 2022
- Last updated
- 19 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 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Wound Healing Efficacy Between MedCu Wound Dressings With Copper Oxide and Negative Pressure Wound Therapy (NPWT/VAC) Treatment
- ClinicalTrials.gov ID
- NCT05215730
- Acronym / sponsor ID
- WD-2C-1012-02-IL
- Keywords
- wound dressings, copper oxide, diabetic ulcers, Negative pressure wound therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- MedCu Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 31 Jan 2022 (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.
Randomized multisite two arms study in which one arm of patients will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm") and the second arm of patients will be treated with MedCu wound dressings with copper oxide (COD) ("Copper Arm"). The study goals are to compare the efficacy, cost and convenience between MedCu Wound Dressings with Copper Oxide (COD) and Negative Pressure Wound Therapy of diabetic foot wounds.
Detailed description
Randomized multisite two arms study: one arm will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm"). The second arm with MedCu wound dressings with copper oxide (COD) ("Copper Arm").
Prior to the commencement of the study the patients will be treated according to the caregiver routine and the wound and patient condition, e.g. surgical or bedside debridement, minor foot amputation and/or various wound dressings. Patients whose foot condition has improved and there is indication for VAC treatment will be randomized to either treatment arm after signing informed consent.
The patients will be then treated for 2-8 weeks with the study treatment.
Treatment termination - Treatment will be stopped due to the following reasons:
- Treatment failure
- Wound deterioration
- Wound infection
- Adverse events
- Inability to continue the current treatment for any other reason unrelated to the treatment modality
- Expected termination (two to eight weeks) - no indication to continue treatment arm or if sufficient granulation has been achieved and the patient is candidate for skin grafting
- Wound closure The VAC treatment will be performed twice weekly, according to the routine practice (usually 75-150 mm Hg). The COD will be changed once a week or more often in highly exudating wounds. The patients will be monitored at least every two weeks in the clinic, but documentation of the wound condition will be obtained in every dressing change or VAC replacement.
Follow-up Period - Patients will be monitored for two additional weekly or biweekly visits (total of 2-4 weeks). The Follow-up Period will be following treatment termination (including wound closure).
In the follow-up period the patient will be treated according to the physician decision based on standard of care, available treatment and wound condition. Continue treatment with the same arm modality, for which the patient had been randomized is allowed and will be recorded. Change into the other arm treatment will be allowed but will be documented as a "Cross Over" and the reason for the cross over will be stated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized multisite two arms study: one arm will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm"). The second arm with MedCu wound dressings with copper oxide (COD) ("Copper Arm").
| Arm | Type | Receives |
|---|---|---|
| Copper oxide dressings (COD) | Active comparator | Device: MedCu wound dressings with copper oxide (COD)MedCu wound dressings with copper oxide (COD) ("Copper Arm"). |
| Vacuum-assisted closure (VAC) treatment ("VAC Arm") | Active comparator | Device: MedCu wound dressings with copper oxide (COD)Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm"). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female subjects, 18 to 85 years of age at the time of enrollment.
- Subject has Diabetes Mellitus (type 1 or type 2) by WHO criteria.
- Wounds in which a decision to treat it with Negative Pressure Wound Therapy (NPWT) has been made due to the wound condition and the physician practice (the wound should be one that deem suitable to NPWT treatment).
- In the case of wounds involving the plantar aspects, they should be without significant bony prominences (unless off-loading can effectively relieve these pressure areas).
- The wound does not have overt signs of infection or if there is residual infection, it is under control and in the process of resolving as evidenced by laboratory tests (within one day prior to study commencement for in-house patients) and clinical judgment.
Key exclusion criteria (22 listed)
- General conditions:
- Laboratory tests:
- Wound condition:
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 wound dressings with copper oxide (COD)Also: Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatmentPatients whose foot wound is indicated for VAC treatment will be randomized to either treatment arm after signing informed consent. | Device | Copper oxide dressings (COD), Vacuum-assisted closure (VAC) treatment ("VAC Arm") |
Primary outcome
Change in wound size
Time frame: 4, 8 and 12 weeks of treatment
The size of the wound will be determined by using a 3D Wound Imaging System
11 secondary outcomes
Physiological parameter - Change in granulation tissue
Time frame: 4, 8 and 12 weeks of treatment
Physiological parameter - Percentage of wounds that will be closed during the study period
Time frame: 12 weeks
Cost of treatment
Time frame: 12 weeks
Convenience - patient perspective - Questionnaire
Time frame: 12 weeks
Convenience - caregiver perspective - Questionnaire
Time frame: 12 weeks
Pain - patients perspective - Questionnaire
Time frame: 12 weeks
Physiological parameter - Infectious episodes
Time frame: 12 weeks
Physiological parameter - Number of treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 12 weeks
Physiological parameter - Change in necrotic tissue
Time frame: 4, 8 and 12 weeks of treatment
Physiological parameter - Change in fibrin tissue
Time frame: 4, 8 and 12 weeks of treatment
Physiological parameter - Average time to wound closure
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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.
Eyal Melamed, MD principal investigator
Rambam Health Care Campus
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 wound dressings with copper oxide (COD) in people with Wounds and Injuries and Negative Pressure Therapy, 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 17 inclusion and 22 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: finished, as of the sponsor's last update on 19 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in wound size (time frame: 4, 8 and 12 weeks of treatment). 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 19 Oct 2023.