Safety and Efficacy Study of MedCu Wound Dressings

NCT04963998 NA COMPLETED

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.

Details

Lead sponsor	MedCu Technologies Ltd.
Phase	NA
Status	COMPLETED
Enrolment	13
Start date	Wed Oct 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Oct 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Wounds and Injuries
• Diabetes Complications

Interventions

• Application of Wound Dressings with Copper Oxide

Countries

Israel