Venous Leg Ulcer
Conditions
Brief summary
The goal of the study is to investigate the effectiveness of Cutimed Sorbact (Study Device) in modifying bacterial load in venous leg ulcers (VLU).
Interventions
DEVICECutimed® Sorbact®
Dialkylcarbomoyl chloride based wound dressing
DEVICEActicoat®
Silver impregnated contact layer dressing
Sponsors
BSN Medical Inc
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the study and products, investigator blinding is unrealistic and subject blinding is unlikely. Research staff will avoid naming the dressing or suggesting the assignment to the subjects. However, an independent monitor with experience in treating wounds will be blinded to the treatment assignment and will confirm healing outcomes based on images.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults, 18 years old and older (i.e. age ≥ 18 years). 2. Venous leg ulcer (VLU) is present on the leg. VLU shall be full thickness but without exposure of deeper tissues (muscle bone or tendon). 3. If more than one ulcer is present, the largest ulcer meeting criteria shall be designated the study ulcer. 4. If more than one ulcer on the study ulcer limb, study ulcer shall be at least one centimeter from other ulcers. 5. Venous Doppler ultrasound exam, within one year from randomization, shall demonstrate reflux of over 0.5 seconds in the affected limb. 6. Ankle-Brachial Pressure Index (ABI) exam with value of ≥0.80 in the affected limb 7. VLU has been treated with silver based therapy for at least 2 weeks within the previous 6 months. 8. VLU present for at least one month prior to screening visit 1. 9. VLU at least 2 cm2 in size but not larger than 100 cm2. 10. After debridement, study ulcer demonstrates a clean wound bed. 11. If subject is a female of childbearing potential, subject must use at least one method of contraception acceptable by PI such as birth control pills, Intrauterine Device (IUD), condoms, or sexual abstinence. At visit 1 urine pregnancy test must be negative. 12. Subject is able to comprehend all study related procedures and adhere to study schedule. 13. Subject is able to provide written informed consent.
Exclusion criteria
1. Based on investigator medical judgment, ulcer is caused by any etiology exclusive of venous insufficiency. 2. Study Ulcer surface area (post-debridement) has increased or decreased by more than 30% in the period between screening visit 1 and treatment visit 1. 3. Study Ulcer exhibits clinical signs and symptoms of infection in the period between screening visit 1 and treatment visit 1 requiring oral antibacterial therapy. 4. Subject has known allergy to any of the materials used in the study. 5. Subject is unable to tolerate multi-layer compression therapy. 6. Based on investigator medical judgment, the Study Ulcer is suspicious for cancer (e.g. basal cell carcinoma or squamous cell carcinoma). 7. In the month prior to screening visit 1 subject was treated with systemic immunosuppressive medications for more than 2 weeks (e.g. chemotherapy, corticosteroids), and/or it is anticipated subject will require such medications during study period. 8. In the month prior to screening visit 1 subject was enrolled in any other research protocol for treatment of Study Ulcer. 9. The Subject has been diagnosed with malignant disease not in remission over the 5 years immediately preceding screening visit 1. (Except: cervical carcinoma in situ, cutaneous squamous cell carcinoma, cutaneous basal cell carcinoma that have been treated and have no evidence of recurrence or metastases). 10. Study ulcer area has been treated with radiation therapy at any time. 11. In the opinion of PI the subject has a medical condition such as autoimmune, renal, hepatic or hematologic disease that makes the subject an inappropriate candidate for participation in study. 12. In the month preceding screening visit 1 Study Ulcer has been treated with advanced tissue engineered devices matrix based devices (e.g., Apligraf, Dermagraft, Oasis). 13. Subject is diagnosed with New York Heart Association Class III and IV congestive heart. 14. Failure: Class III: Symptoms with moderate exertion or, Class IV: Symptoms at rest. 15. Subject is diagnosed with diabetes mellitus that is poorly controlled and shall be defined as hemoglobin A1C \>10%. 16. Study Ulcer is completely or more than 50% of the Study Ulcer is located on the foot (i.e. below the malleolus). 17. Subject is a female of childbearing potential, and refusing to use at least one method of contraception acceptable by PI such as birth control pills, IUD, condoms, or sexual abstinence. 18. Positive pregnancy test in screening visit 1 in a female of childbearing potential or active pregnancy or breast-feeding. 19. In the opinion of the PI the subject is unable to understand or comply with study related protocol including but not limited to providing informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bacterial Load | Baseline, Up to 8 weeks | Mean change in bacterial load in Colony Forming Units (CFU)/grams will be assessed from tissue samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing Rate | Up 6 weeks | Wound healing rate (in cm\^2/week) will be calculated by measuring the wound area |
| Pain as Measured by VAS Scores | Up to 8 weeks | The Pain Visual Analog Scale (VAS) has range from 0 (no pain) to 100 (worst possible pain). Mean change in scores will be reported from last visit compared to baseline will be reported. |
| Percentage of Subjects With Complete Healing | Up to 8 weeks | The percentage of subjects achieving complete healing of ulcer at the evaluation of treating physician will be reported |
| EQ-5D-5L Quality of Life Scores | Up to 8 weeks | The Euro Quality of life-5-Dimension-5-Level (EQ-5D-5L) is averaged based off the 5 point scale, where 0 is no problems and 5 is extreme problems. Difference in scores will be reported from last visit compared to baseline will be reported. |
| Number of Adverse Events | Up to 8 weeks | As assessed by treating physician |
| Wound Quality of Life (WQoL) Scores | Up to 8 weeks | WQoL is a 17 item questionnaire with each question scored on a 5 point scale, where 0 is not at all and 5 is very much. WQoL has a total score ranging from 0 to 85 with a lower score indicating better quality of life. Mean change in scores will be reported from last visit compared to baseline will be reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cutimed® Sorbact® Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing | 15 |
| Acticoat® Participants in this group will receive the Acticoat intervention for 6 weeks.
Acticoat®: Silver impregnated contact layer dressing | 16 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of healing | 0 | 2 |
| Overall Study | Lack of Improvement | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Preference to receive wound care closer to home | 1 | 0 |
Baseline characteristics
| Characteristic | Cutimed® Sorbact® | Total | Acticoat® |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 9 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 22 Participants | 12 Participants |
| Age, Continuous | 59.33 years STANDARD_DEVIATION 12.81 | 58.77 years STANDARD_DEVIATION 11.46 | 58.25 years STANDARD_DEVIATION 10.44 |
| Childbearing potential | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 14 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 17 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 173.44 centimeters STANDARD_DEVIATION 11.8 | 173.0 centimeters STANDARD_DEVIATION 11.19 | 172.93 centimeters STANDARD_DEVIATION 10.95 |
| Length of tobacco use | 26.5 years (mean) STANDARD_DEVIATION 13.43 | 25.29 years (mean) STANDARD_DEVIATION 14.29 | 24.69 years (mean) STANDARD_DEVIATION 16.48 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 19 Participants | 10 Participants |
| Sex: Female, Male Female | 7 Participants | 14 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 9 Participants |
| Tobacco cessation years | 23 years STANDARD_DEVIATION 17.3 | 17.5 years STANDARD_DEVIATION 10.77 | 12 years STANDARD_DEVIATION 4.24 |
| Tobacco use | 15 Participants | 31 Participants | 16 Participants |
| Weight | 90.84 kilograms STANDARD_DEVIATION 20.73 | 94.12 kilograms STANDARD_DEVIATION 20.64 | 97.93 kilograms STANDARD_DEVIATION 21.68 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 3 / 15 | 2 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 |
Outcome results
Primary
Change in Bacterial Load
Mean change in bacterial load in Colony Forming Units (CFU)/grams will be assessed from tissue samples
Time frame: Baseline, Up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cutimed® Sorbact® | Change in Bacterial Load | 12678.81 CFU/gram | Standard Deviation 23698.6 |
| Acticoat® | Change in Bacterial Load | 33190.8 CFU/gram | Standard Deviation 57882.61 |
Secondary
EQ-5D-5L Quality of Life Scores
The Euro Quality of life-5-Dimension-5-Level (EQ-5D-5L) is averaged based off the 5 point scale, where 0 is no problems and 5 is extreme problems. Difference in scores will be reported from last visit compared to baseline will be reported.
Time frame: Up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cutimed® Sorbact® | EQ-5D-5L Quality of Life Scores | 0.12 units on a scale | Standard Deviation 0.23 |
| Acticoat® | EQ-5D-5L Quality of Life Scores | 0.08 units on a scale | Standard Deviation 0.13 |
Secondary
Number of Adverse Events
As assessed by treating physician
Time frame: Up to 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cutimed® Sorbact® | Number of Adverse Events | 3 number of adverse events |
| Acticoat® | Number of Adverse Events | 2 number of adverse events |
Secondary
Pain as Measured by VAS Scores
The Pain Visual Analog Scale (VAS) has range from 0 (no pain) to 100 (worst possible pain). Mean change in scores will be reported from last visit compared to baseline will be reported.
Time frame: Up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cutimed® Sorbact® | Pain as Measured by VAS Scores | .43 units on a scale | Standard Deviation 34.9 |
| Acticoat® | Pain as Measured by VAS Scores | -16.9 units on a scale | Standard Deviation 18.9 |
Secondary
Percentage of Subjects With Complete Healing
The percentage of subjects achieving complete healing of ulcer at the evaluation of treating physician will be reported
Time frame: Up to 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cutimed® Sorbact® | Percentage of Subjects With Complete Healing | 20 percent of patients |
| Acticoat® | Percentage of Subjects With Complete Healing | 0 percent of patients |
Secondary
Wound Healing Rate
Wound healing rate (in cm\^2/week) will be calculated by measuring the wound area
Time frame: Up 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cutimed® Sorbact® | Wound Healing Rate | .179 cm^2/week | Standard Deviation 0.272 |
| Acticoat® | Wound Healing Rate | .122 cm^2/week | Standard Deviation 0.258 |
Secondary
Wound Quality of Life (WQoL) Scores
WQoL is a 17 item questionnaire with each question scored on a 5 point scale, where 0 is not at all and 5 is very much. WQoL has a total score ranging from 0 to 85 with a lower score indicating better quality of life. Mean change in scores will be reported from last visit compared to baseline will be reported.
Time frame: Up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cutimed® Sorbact® | Wound Quality of Life (WQoL) Scores | -9.1 units on a scale | Standard Deviation 14.5 |
| Acticoat® | Wound Quality of Life (WQoL) Scores | -4.1 units on a scale | Standard Deviation 11.1 |