Efficacy of Wound Dressings With Copper Oxide

NCT04634838 | Terminated

• 1 other identifier: 002-20-LOE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. The efficacy of the two types of dressings in reducing the size and improving the condition of the wounds will be compared.

Conditions

Pressure Ulcer; Diabetic Foot Ulcer

Keywords

wound dressings; copper oxide; silver; wound healing

Outcome Measures

Primary Outcomes (1)

• 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.

  9 weeks

Secondary Outcomes (2)

• Percent of granulation tissue

  9 weeks

• Number of infectious episodes

  9 weeks

Study Arms (1)

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.

Device: MedCu Antibacterial Wound Dressings with Copper Oxide

Interventions

MedCu Antibacterial Wound Dressings with Copper Oxide DEVICE

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

MedCu Antibacterial Wound Dressings with Copper Oxide

Eligibility Criteria

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

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• MedCu Technologies Ltd.: lead

Study Sites (1)

Loewenstein Rehabilitation Center

Raanana, Israel

Location

MeSH Terms

Conditions

Pressure Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 18, 2020
• Study Start: February 2, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-03

Locations

IL (1)