Clinical trial NCT04634838: Efficacy of Wound Dressings With Copper Oxide
Official title: Pilot Efficacy Study of MedCu Wound Dressings With Copper Oxide in Treating Pressure Sores and Post-op Wounds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pressure Ulcer
Diabetic Foot Ulcer
Keywords: wound dressings
copper oxide
silver
wound healing
Lead sponsor: MedCu Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Wound size 2-30 cm2.
2. Non-infected wounds.
3. 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.
4. Having a body mass index (BMI) \<40 Kg/m2.
5. Glycosylated haemoglobin (HbA1c) \<12.0%.
6. Not undergoing any systemic or topical antibiotic treatment for the wound for a week before enrollment in the study.
7. The patient is able and eligible to sign written informed consent and participate in the study.
8. Be available for the entire study period, and ability and willingness to adhere to the requirements of the study.
9. 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)

Exclusion Criteria:

1. A clinically significant active or unstable cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease.
2. Psychiatric condition.
3. Active participation in an investigational trial within 30 days of the screening visit.
4. History of allergic reactions attributed to copper.
5. Patient with known allergy to at least thee drugs or other substances.
6. Any chronic or acute condition susceptible of interfering with the evaluation of the wound dressing effect.
7. Individuals using and need to continue use any type of topical agents in or on the wound.
8. 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.
9. Females who are pregnant, lactating, of child-bearing potential.
10. Fertile female subjects who are not willing to use an acceptable method of contraception during the study.
11. Subjects who are likely to be non-compliant or uncooperative during the study.

    Wound related parameters:
12. The size of the wounds is reduced by more than 50% during the three weeks presiding the study.
13. Wounds in which local pressure cannot be avoided due to protruding bone, or any other complex rehabilitation procedure.
14. Wounds determined to be infected wounds.
15. Wounds that are considered to necessitate debridement in the operation room during the study.
16. Wounds that necessitate antibiotic treatment or needed antibiotic treatment one week prior to the trial.
17. Necrotic wounds.
18. Wound with tunnels of more than 3 cm.

    Lab parameters:
19. Hemoglobin below 7.0 g/dl
20. White blood cells count \> 14,000/ul
21. Albumin \<2.5 g/dl

Primary outcomes:
measure: Percent reduction of wound size
timeFrame: 9 weeks
Secondary outcomes:
measure: Percent of granulation tissue
timeFrame: 9 weeks
measure: Number of infectious episodes
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Ra'anana
country: Israel
facility: Loewenstein Rehabilitation Center
Study officials:
References: