NCT05215730

Comparison of Wound Healing Between MedCu Dressings With Copper Oxide and Negative Pressure Wound Therapy Treatment

Comparison of Wound Healing Efficacy Between MedCu Wound Dressings With Copper Oxide and Negative Pressure Wound Therapy (NPWT/VAC) Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: MedCu Technologies Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Randomized multisite two arms study in which one arm of patients will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm") and the second arm of patients will be treated with MedCu wound dressings with copper oxide (COD) ("Copper Arm"). The study goals are to compare the efficacy, cost and convenience between MedCu Wound Dressings with Copper Oxide (COD) and Negative Pressure Wound Therapy of diabetic foot wounds.

Detailed description

Randomized multisite two arms study: one arm will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm"). The second arm with MedCu wound dressings with copper oxide (COD) ("Copper Arm"). Prior to the commencement of the study the patients will be treated according to the caregiver routine and the wound and patient condition, e.g. surgical or bedside debridement, minor foot amputation and/or various wound dressings. Patients whose foot condition has improved and there is indication for VAC treatment will be randomized to either treatment arm after signing informed consent. The patients will be then treated for 2-8 weeks with the study treatment. Treatment termination - Treatment will be stopped due to the following reasons: 1. Treatment failure 1. Wound deterioration 2. Wound infection 3. Adverse events 2. Inability to continue the current treatment for any other reason unrelated to the treatment modality 3. Expected termination (two to eight weeks) - no indication to continue treatment arm or if sufficient granulation has been achieved and the patient is candidate for skin grafting 4. Wound closure The VAC treatment will be performed twice weekly, according to the routine practice (usually 75-150 mm Hg). The COD will be changed once a week or more often in highly exudating wounds. The patients will be monitored at least every two weeks in the clinic, but documentation of the wound condition will be obtained in every dressing change or VAC replacement. Follow-up Period - Patients will be monitored for two additional weekly or biweekly visits (total of 2-4 weeks). The Follow-up Period will be following treatment termination (including wound closure). In the follow-up period the patient will be treated according to the physician decision based on standard of care, available treatment and wound condition. Continue treatment with the same arm modality, for which the patient had been randomized is allowed and will be recorded. Change into the other arm treatment will be allowed but will be documented as a "Cross Over" and the reason for the cross over will be stated.

Conditions

• Wounds and Injuries
• Negative Pressure Therapy
• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	MedCu wound dressings with copper oxide (COD)	Patients whose foot wound is indicated for VAC treatment will be randomized to either treatment arm after signing informed consent.

Timeline

• Start date: 2021-07-07
• Primary completion: 2023-10-10
• Completion: 2023-10-10
• First posted: 2022-01-31
• Last updated: 2023-10-19

Locations

1 site across 1 country: Israel