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Safety and Efficacy Study of MedCu Wound Dressings

NCT04963998 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-07-15

No results posted yet for this study

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

Conditions

  • Wounds and Injuries
  • Diabetes Complications

Interventions

DEVICE

Application of Wound Dressings with Copper Oxide

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

Sponsors & Collaborators

  • MedCu Technologies Ltd.

    lead INDUSTRY

Principal Investigators

  • Alexei Rovitsky, MD · Rambam Health Care Campus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-02
Primary Completion
2020-10-21
Completion
2020-10-21

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04963998 on ClinicalTrials.gov