Comparison of Wound Healing Between MedCu Dressings With Copper Oxide and Negative Pressure Wound Therapy Treatment

NCT05215730 | Completed

• 1 other identifier: WD-2C-1012-02-IL
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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"). 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.

Conditions

Wounds and Injuries; Negative Pressure Therapy; Diabetic Foot Ulcer

Keywords

wound dressings; copper oxide; diabetic ulcers; Negative pressure wound therapy

Outcome Measures

Primary Outcomes (1)

• Change in wound size

  The size of the wound will be determined by using a 3D Wound Imaging System

  4, 8 and 12 weeks of treatment

Secondary Outcomes (11)

• Physiological parameter - Change in granulation tissue

  4, 8 and 12 weeks of treatment

• Physiological parameter - Percentage of wounds that will be closed during the study period

  12 weeks

• Cost of treatment

  12 weeks

• Convenience - patient perspective - Questionnaire

  12 weeks

• Convenience - caregiver perspective - Questionnaire

  12 weeks

Study Arms (2)

Copper oxide dressings (COD)

ACTIVE COMPARATOR

MedCu wound dressings with copper oxide (COD) ("Copper Arm").

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").

Device: MedCu wound dressings with copper oxide (COD)

Interventions

MedCu wound dressings with copper oxide (COD) DEVICE

Patients whose foot wound is indicated for VAC treatment will be randomized to either treatment arm after signing informed consent.

Also known as: Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment

Copper oxide dressings (COD); Vacuum-assisted closure (VAC) treatment ("VAC Arm")

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• General conditions:
• Unstable cardiac disease or other medical conditions with expected repeated hospitalizations during the study phase.
• 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.
• 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.

Sponsors & Collaborators

• MedCu Technologies Ltd.: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, 31906, Israel

Location

MeSH Terms

Conditions

Wounds and Injuries; Diabetic Foot

Interventions

Negative-Pressure Wound Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Eyal Melamed, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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").

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 31, 2022
• Study Start: July 7, 2021
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

IL (1)