Safety and Efficacy Study of MedCu Wound Dressings

NCT04963998 | Completed

• 1 other identifier: WD-2C-1010-01-IL
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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 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

1. 1.Percent change in wound size during the Treatment Phase,
2. 2.Rate of increase in extent and quality (color) of granulation tissue,
3. 3.Infectious episodes during the Treatment Phase.

Conditions

Wounds and Injuries; Diabetes Complications

Keywords

wound dressings; copper oxide; diabetic ulcers

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (3)

• Percent change in wound size

  4 weeks

• Rate of change in extent and quality (color) of granulation tissue

  4 weeks

• Rate of change in percent of fibrin tissue

  4 weeks

Study Arms (1)

Copper oxide dressings

EXPERIMENTAL

Treatment of diabetic ulcers that were in a stagnated stage with copper oxide containing wound dressings

Device: Application of Wound Dressings with Copper Oxide

Interventions

Application of Wound Dressings with Copper Oxide DEVICE

Application of Wound Dressings with Copper Oxide on chronic foot wounds in diabetic patients

Copper oxide dressings

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• MedCu Technologies Ltd.: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

MeSH Terms

Conditions

Wounds and Injuries; Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Alexei Rovitsky, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 15, 2021
• Study Start: October 2, 2019
• Primary Completion: October 21, 2020
• Study Completion: October 21, 2020
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)