Wounds and InjuriesNCT04963998
Safety and Efficacy Study of MedCu Wound Dressings
A study testing Application of Wound Dressings with Copper Oxide in people with Wounds and Injuries and Diabetes Complications, run by MedCu Technologies Ltd. at 1 site in Israel.
Trial summary
The Study was divided into three Phases: Screening Phase (1-2 weeks); Treatment Phase (~ 1 month); and Follow-up Phase (two weeks). During the Screening Phase, blood samples were taken for analysis of blood count, liver and kidney functions from potential appropriate diabetic patients with chronic wounds in their… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Wounds and Injuries, Diabetes Complications
- What is being tested?
- Application of Wound Dressings with Copper Oxide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Oct 2019to 21 Oct 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must satisfy all of the following inclusion criteria to be included in the study:
- Male or female subjects, 18 to 80 years of age at the time of enrollment.
- Subject has Diabetes Mellitus (type 1 or type 2) by WHO criteria.
- Wound exists for at least 4 weeks including 4 weeks from last surgical debridement in operating room (OR) or minor foot amputation.
- The foot wound size has not decreased by more than 25% per week or 35% in two weeks by SOC during the screening period.
- Wound size 2-30 cm2.
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- The wound does not have signs of infection as defined by Dumville et al., Topical antimicrobial agents for treating foot wounds in people with diabetes. Cochrane Database of Systematic Reviews 2017, Issue 6. Art. No.: CD011038, Table 1. For clarity, the following signs are allowed:
- If erythema is present at wound it should be up to 2 cm from the wound edges.
- If exudate is present it should be either serous or thick but not thick-purulent nor purulent
- Green or black necrotic tissue constitute up to 20% of the wound size.
- The wound should not have cavities or deep sinuses. However, cover by free skin or soft tissue wall is allowed for up to 5 mm.
- 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.
- Recent glycosylated haemoglobin (HbA1c) <12.0%.
- Not undergoing any systemic or topical antibiotic treatment for the wound for a week before enrollment in the study.
- No foot deformity or bony projection that is severe enough to jeopardize wound healing as deemed to the treating physician.
- 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
- Patients will be excluded from the study if they meet any of the following exclusion criteria:
- General conditions:
- 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.
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- Subjects with Active Charcot neuro-arthropathy.
- Any chronic or acute condition susceptible of interfering with the evaluation of the wound dressing effect.
- 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 treatment period and for 14 days following completion of treatment.
- Subjects who are likely to be non-compliant or uncooperative during the study.
- Laboratory tests:
- Anemia (Hemoglobin < 8.0 g/dL).
- White Blood Cells count > 11,000/μL.
- Platelets count < 100,000/μL.
- Liver function tests > 3 times upper normal lab values.
- Creatinine > 3.5 mg/dL.
- Albumin < 2.2g/dL.
- Any other clinically significant blood and urinalysis tests abnormalities that can jeopardize study results as evaluated by the investigator.
- Wound condition:
- The wound size area has decreased by more than 25% per week or 35% in two weeks by SOC treatment during the screening phase prior to the commencement of the study.
- Have visible bone exposed at wound site.
- Any signs of infection in the wound (which could be linked to raised body temperature), abscess, cellulitis, necrosis, drainage or known osteomyelitis or erythema around the wound of more than 2 cm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy Study of MedCu Wound Dressings With Copper Oxide
The Study was divided into three Phases: Screening Phase (1-2 weeks); Treatment Phase (~ 1 month); and Follow-up Phase (two weeks). During the Screening Phase, blood samples were taken for analysis of blood count, liver and kidney functions from potential appropriate diabetic patients with chronic wounds in their foot. Stable chronic diabetic patients, whose wounds were not infected and the wound size increased or did not decreased by more than 25% per week or 35% by SOC treatment during the Screening Phase, and who will meet all other study inclusion criteria, were enrolled and start the 4 weeks Treatment Phase. The wounds were then treated by applying the Copper Oxide containing Dressings (COD) that were changed twice a week. In the two weeks post-treatment period, the patient received standard of care (SOC) dressing. In that time period, the patient were seen once after two weeks. The Primary outcome was the evaluation of the safety of the COD and the secondary outcomes were the evaluation of the wound size change of the foot wounds when using COD. Measures that were assessed included
- Percent change in wound size during the Treatment Phase,
- Rate of increase in extent and quality (color) of granulation tissue,
- Infectious episodes during the Treatment Phase.
Read the detailed description
The Study was divided into three Phases: Screening Phase (1-2 weeks); Treatment Phase (~ 1 month); and Follow-up Phase (two weeks). During the Screening Phase, blood samples were taken for analysis of blood count, liver and kidney functions from potential appropriate diabetic patients with chronic wounds in their foot. Stable chronic diabetic patients, whose wounds were not infected and the wound size increased or did not decreased by more than 25% per week or 35% by SOC treatment during the Screening Phase, and who will meet all other study inclusion criteria, were enrolled and start the 4 weeks Treatment Phase.
During the Treatment Phase, the index wounds were evaluated, undergone bed side debridement if necessary, and photographed. Tissue Analytics software was used to assess wound size and volume. The wounds were washed by normal saline or a previously used solution (but no new disinfectant or any antibacterial preparation), and then the COD was applied on the wound. The COD was applied on the wounds for the duration of the Treatment Phase and changed twice a week, once in the clinic and once at home. At every clinic visit the following assessments were performed: wound assessment, including size determination, depth, clinical impression of infection (swelling, erythema, discharge quantity and quality, granulation, fibrin and necrotic tissue, odor, pain, and tenderness); antibiotics and vital signs as necessary. After ~ 1 month of test wound dressings use, a blood sample was taken for blood count, liver and kidney functions. If needed, the patients' wounds were treated using the hospital SOC in the follow up period. The Primary outcome was the evaluation of the safety of the COD and the secondary outcomes were the evaluation of the wound size change of the foot wounds when using COD. Measures that were assessed included
- Percent change in wound size during the Treatment Phase,
- Rate of increase in extent and quality (color) of granulation tissue,
- Infectious episodes during the Treatment Phase.
- Conditions
- Wounds and Injuries, Diabetes Complications
- Being tested
- Application of Wound Dressings with Copper Oxide
- Keywords
- wound dressings, copper oxide, diabetic ulcers
- Medical subject headings
- Wounds and Injuries, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Wound Dressings with Copper OxideDevice
Application of Wound Dressings with Copper Oxide on chronic foot wounds in diabetic patients
| Study group | Role | What they receive |
|---|---|---|
| Copper oxide dressings | Experimental | Treatment of diabetic ulcers that were in a stagnated stage with copper oxide containing wound dressings Receives: Device: Application of Wound Dressings with Copper Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events as assessed by determination
- Vital signs
- Physical Examination of the treated wound
- Sensitivity to the wound dressing
- Complete Blood Tests, which include complete blood counts (CBC), Liver and Kidney Function tests, and C-reactive protein (CRP)
- Concomitant medication use.
Measured: 4 weeks
Secondary outcomes (3)
Percent change in wound size
The percent of wound size of the foot wounds when using Wound Dressings with Copper Oxide (COD) was determined by using Tissue Analytics 3D Wound Imaging System. At each time point the size of the wound was compared to the initial size of the wound when starting using the COD.
Measured: 4 weeks
Rate of change in extent and quality (color) of granulation tissue
The extent and quality of the color of the wound tissue was assessed by using both the Tissue Analytics 3D Wound Imaging System and physicians clinical evaluation. The percent of the granulation tissue at each time point was compared to the initial quality of the granulation tissue at the beginning of the treatment with the COD.
Measured: 4 weeks
Rate of change in percent of fibrin tissue
The percent of change in the percent of fibrin tissue was analyzed the Tissue Analytics 3D Wound Imaging System and by the physicians clinical evaluation. The percent of the fibrin tissue at each time point was compared to the initial percent of the fibrin tissue at the beginning of the treatment with the COD.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start2 Oct 2019
- Primary completion21 Oct 2020
- Study completion21 Oct 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedCu Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexei Rovitsky, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963998
- Sponsor's protocol ID
- WD-2C-1010-01-IL
- Status last verified
- Jul 2021
- First submitted
- 28 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of MedCu Wound Dressings With Copper Oxide
- ClinicalTrials.gov ID
- NCT04963998
- Acronym / sponsor ID
- WD-2C-1010-01-IL
- Conditions
- Wounds and Injuries, Diabetes Complications
- Keywords
- wound dressings, copper oxide, diabetic ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- MedCu Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 15 Jul 2021 (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 Study was divided into three Phases: Screening Phase (1-2 weeks); Treatment Phase (~ 1 month); and Follow-up Phase (two weeks). During the Screening Phase, blood samples were taken for analysis of blood count, liver and kidney functions from potential appropriate diabetic patients with chronic wounds in their foot. Stable chronic diabetic patients, whose wounds were not infected and the wound size increased or did not decreased by more than 25% per week or 35% by SOC treatment during the Screening Phase, and who will meet all other study inclusion criteria, were enrolled and start the 4 weeks Treatment Phase. The wounds were then treated by applying the Copper Oxide containing Dressings (COD) that were changed twice a week. In the two weeks post-treatment period, the patient received standard of care (SOC) dressing. In that time period, the patient were seen once after two weeks. The Primary outcome was the evaluation of the safety of the COD and the secondary outcomes were the evaluation of the wound size change of the foot wounds when using COD. Measures that were assessed included
- Percent change in wound size during the Treatment Phase,
- Rate of increase in extent and quality (color) of granulation tissue,
- Infectious episodes during the Treatment Phase.
Detailed description
The Study was divided into three Phases: Screening Phase (1-2 weeks); Treatment Phase (~ 1 month); and Follow-up Phase (two weeks). During the Screening Phase, blood samples were taken for analysis of blood count, liver and kidney functions from potential appropriate diabetic patients with chronic wounds in their foot. Stable chronic diabetic patients, whose wounds were not infected and the wound size increased or did not decreased by more than 25% per week or 35% by SOC treatment during the Screening Phase, and who will meet all other study inclusion criteria, were enrolled and start the 4 weeks Treatment Phase.
During the Treatment Phase, the index wounds were evaluated, undergone bed side debridement if necessary, and photographed. Tissue Analytics software was used to assess wound size and volume. The wounds were washed by normal saline or a previously used solution (but no new disinfectant or any antibacterial preparation), and then the COD was applied on the wound. The COD was applied on the wounds for the duration of the Treatment Phase and changed twice a week, once in the clinic and once at home. At every clinic visit the following assessments were performed: wound assessment, including size determination, depth, clinical impression of infection (swelling, erythema, discharge quantity and quality, granulation, fibrin and necrotic tissue, odor, pain, and tenderness); antibiotics and vital signs as necessary. After ~ 1 month of test wound dressings use, a blood sample was taken for blood count, liver and kidney functions. If needed, the patients' wounds were treated using the hospital SOC in the follow up period. The Primary outcome was the evaluation of the safety of the COD and the secondary outcomes were the evaluation of the wound size change of the foot wounds when using COD. Measures that were assessed included
- Percent change in wound size during the Treatment Phase,
- Rate of increase in extent and quality (color) of granulation tissue,
- Infectious episodes during the Treatment Phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Copper oxide dressings | Experimental | Device: Application of Wound Dressings with Copper OxideTreatment of diabetic ulcers that were in a stagnated stage with copper oxide containing wound dressings |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must satisfy all of the following inclusion criteria to be included in the study:
- Male or female subjects, 18 to 80 years of age at the time of enrollment.
- Subject has Diabetes Mellitus (type 1 or type 2) by WHO criteria.
- Wound exists for at least 4 weeks including 4 weeks from last surgical debridement in operating room (OR) or minor foot amputation.
- The foot wound size has not decreased by more than 25% per week or 35% in two weeks by SOC during the screening period.
Key exclusion criteria (25 listed)
- Patients will be excluded from the study if they meet any of the following exclusion criteria:
- 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 |
|---|---|---|
| Application of Wound Dressings with Copper OxideApplication of Wound Dressings with Copper Oxide on chronic foot wounds in diabetic patients | Device | Copper oxide dressings |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 4 weeks
Incidence of Treatment-Emergent Adverse Events as assessed by determination * Vital signs * Physical Examination of the treated wound * Sensitivity to the wound dressing * Complete Blood Tests, which include complete blood counts (CBC), Liver and Kidney Function tests, and C-reactive protein (CRP) * Concomitant medication use.
3 secondary outcomes
Percent change in wound size
Time frame: 4 weeks
Rate of change in extent and quality (color) of granulation tissue
Time frame: 4 weeks
Rate of change in percent of fibrin tissue
Time frame: 4 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 15 Jul 2021.
- 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.
Alexei Rovitsky, 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 Application of Wound Dressings with Copper Oxide in people with Wounds and Injuries and Diabetes Complications, 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 18 inclusion and 25 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 15 Jul 2021. 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?
Incidence of Treatment-Emergent Adverse Events (time frame: 4 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 15 Jul 2021.