NCT04963998

Safety and Efficacy Study of MedCu Wound Dressings

Safety and Efficacy Study of MedCu Wound Dressings With Copper Oxide

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: MedCu Technologies Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. During the Treatment Phase, the index wounds were evaluated, undergone bed side debridement if necessary, and photographed. Tissue Analytics software was used to assess wound size and volume. The wounds were washed by normal saline or a previously used solution (but no new disinfectant or any antibacterial preparation), and then the COD was applied on the wound. The COD was applied on the wounds for the duration of the Treatment Phase and changed twice a week, once in the clinic and once at home. At every clinic visit the following assessments were performed: wound assessment, including size determination, depth, clinical impression of infection (swelling, erythema, discharge quantity and quality, granulation, fibrin and necrotic tissue, odor, pain, and tenderness); antibiotics and vital signs as necessary. After \~ 1 month of test wound dressings use, a blood sample was taken for blood count, liver and kidney functions. If needed, the patients' wounds were treated using the hospital SOC in the follow up period. 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

Type	Name	Description
DEVICE	Application of Wound Dressings with Copper Oxide	Application of Wound Dressings with Copper Oxide on chronic foot wounds in diabetic patients

Timeline

• Start date: 2019-10-02
• Primary completion: 2020-10-21
• Completion: 2020-10-21
• First posted: 2021-07-15
• Last updated: 2021-07-15

Locations

1 site across 1 country: Israel