Chronic Ulcer, Diabetic Foot Ulcer, Pressure Ulcer, Skin Tear, Trauma Injury, Venous Leg Ulcer
Conditions
Brief summary
The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss of these subjects). The subjects will receive up to 16 RD1 applications. In case of complete healing, subject will be called for one confirmatory visit two weeks later or before discharge from the SNF (the earlier of the two). Subject data will be kept in each site's records. All diabetic subjects' glycemic management will be performed by a qualified physician. All subjects will have wound care specialist or wound surgeon or dermatologist involved in their wound care
Interventions
DEVICERD1 System
The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.
Sponsors
RedDress Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is ≥18 years of age * Patient with a wound deemed suitable for treatment with RD1 * Ulcer free of clinical signs of infection. * Post-debridement, ulcer free of necrotic tissue. * For foot ulcers, Subject has adequate vascular perfusion of the affected limb, as defined by - Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2 * HbA1c ≤ 12.0% (diabetic patients) * Subject or legal authorized representative must be willing to comply with the protocol including having blood drawn to create the RD1. * Female subjects who are capable of conceiving must use an acceptable form of contraception in order to participate in the study (acceptable forms of contraception include condoms for males and contraceptive pills or IUDs for women).
Exclusion criteria
* If ulcer area decreases by ≥ 30% during the initial 2-week screening (± 2 days) and standard of care phase, or if the ulcer area increases ≥ 30%, * Presence of active underlying osteomyelitis. * Patient with a proven sepsis established by a blood culture in the past 2 weeks, or confirmed active infection likely to interfere with trial, such as urine tract infection * Known malignancy in the reference wound bed or margins of the wound * Exposure of blood vessels or organs at the base of the reference wound * History of alcohol or substance abuse, within the previous 2 months * Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug or treatment within 30 days of day 0 visit. * Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with, or affect the rate and quality of, wound healing (e.g., systemic steroids (more than 10mg per day), immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy within the past 12 months, dialysis, radiation therapy to the ulcer area, vascular surgery, angioplasty or thrombolysis). * Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes within 30 days of randomization or is scheduled to receive during the study. * Subject has been treated with hyperbaric oxygen within 5 days of screening or is scheduled to receive during the study. * Wound on a patient who has a life expectancy of less than 6 months. * Cannot withdraw blood in the required amount technically. * Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Patients who are taking orally Coumadin, Aspirin, or Plavix (clopidogrel) will not be excluded. * Hemoglobin anemia (\< 9 g/dL). * Subject has an infectious disease, such as Acquired Immune Deficiency Disease (AIDS) or HIV, Hepatitis C, Hepatitis B, Human T-lymphotropic virus or Syphilis * Women who are pregnant or currently breast feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reduction in Wound Size | 16 weeks | Numer of patients showed Percent of wound reduction from baseline to end of treatment in the intent to treat (ITT) population |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RD1 System The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.
RD1 System: The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Early termination | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | RD1 System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 13 |
| other Total, other adverse events | 5 / 13 |
| serious Total, serious adverse events | 1 / 13 |
Outcome results
Primary
Number of Participants With Reduction in Wound Size
Numer of patients showed Percent of wound reduction from baseline to end of treatment in the intent to treat (ITT) population
Time frame: 16 weeks
Population: Number of patients showed Percent of wound reduction in the intent to treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RD1 System | Number of Participants With Reduction in Wound Size | 7 participants with Wound Size reduction |