Safety and Efficacy Study of MedCu Wound Dressings

Conditions

Diabetes Complications, Wounds and Injuries

Keywords

wound dressings, copper oxide, diabetic ulcers

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. 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.

Related papers

No related papers found yet.

Interventions

DEVICEApplication of Wound Dressings with Copper Oxide

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

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

No

Inclusion criteria

Patients must satisfy all of the following inclusion criteria to be included in the study: 1. Male or female subjects, 18 to 80 years of age at the time of enrollment. 2. Subject has Diabetes Mellitus (type 1 or type 2) by WHO criteria. 3. Wound exists for at least 4 weeks including 4 weeks from last surgical debridement in operating room (OR) or minor foot amputation. 4. The foot wound size has not decreased by more than 25% per week or 35% in two weeks by SOC during the screening period. 5. Wound size 2-30 cm2. 6. 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: 1. If erythema is present at wound it should be up to 2 cm from the wound edges. 2. If exudate is present it should be either serous or thick but not thick-purulent nor purulent 3. Green or black necrotic tissue constitute up to 20% of the wound size. 7. 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. 8. 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. 9. Having a body mass index (BMI) \<40 Kg/m2. 10. Recent glycosylated haemoglobin (HbA1c) \<12.0%. 11. Not undergoing any systemic or topical antibiotic treatment for the wound for a week before enrollment in the study. 12. No foot deformity or bony projection that is severe enough to jeopardize wound healing as deemed to the treating physician. 13. The patient is able and eligible to sign written informed consent and participate in the study. 14. Be available for the entire study period, and ability and willingness to adhere to the requirements of the study.

Exclusion criteria

Patients will be excluded from the study if they meet any of the following

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events	4 weeks	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.

Secondary

Measure	Time frame	Description
Percent change in wound size	4 weeks	The percent of wound size of the foot wounds when using Wound Dressings with Copper Oxide (COD) was determined by using Tissue Analytics 3D Wound Imaging System. At each time point the size of the wound was compared to the initial size of the wound when starting using the COD.
Rate of change in extent and quality (color) of granulation tissue	4 weeks	The extent and quality of the color of the wound tissue was assessed by using both the Tissue Analytics 3D Wound Imaging System and physicians clinical evaluation. The percent of the granulation tissue at each time point was compared to the initial quality of the granulation tissue at the beginning of the treatment with the COD.
Rate of change in percent of fibrin tissue	4 weeks	The percent of change in the percent of fibrin tissue was analyzed the Tissue Analytics 3D Wound Imaging System and by the physicians clinical evaluation. The percent of the fibrin tissue at each time point was compared to the initial percent of the fibrin tissue at the beginning of the treatment with the COD.

Countries

Israel

Outcome results

None listed