Diabetic Foot Ulcers, Pressure Ulcers, Venous Ulcers
Conditions
Keywords
Chronic, Non-healing, Wounds
Brief summary
This study will examine differences in the process of wound-healing in patients treated with platelet rich plasma (a concentration of proteins derived from a patients own blood) applied to the wound as a gel; injected into the wound or surrounding tissue; or both; compared to patients treated with usual medical treatment . This study seeks to enroll patients who are 18 or older with a non-healing skin wound that is at least 30 days old. Only patients with Diabetic Foot Ulcers, Venous Ulcers, or Pressure Ulcers will be included in the study.
Detailed description
The proposed investigation is designed to solicit a large number of patients (N=1,500) with non-healing wounds (Diabetic Foot Ulcers, Venous Ulcers, or Pressure Ulcers) that have not responded to standard wound care in the previous 30 days or more. A prospective, interventional, single-blinded, controlled, registry trial will be used. Data will be analyzed to compare patients who received PRP therapy (PRP gel application, PRP injection, or both) and standard wound care (usual customary care) with patients who received standard wound care (usual customary care), only. Wound size, rate of healing, quality of life, and recurrence of wound will be measured during the 16-week period at usual office visits. Hypotheses to be tested: 1. Treatment of a chronic wound with standard of care and autologous platelet rich plasma (PRP) will increase the velocity of healing (rate of wound closure) over a twenty week period as compared to patients receiving standard wound care only (Control Group), which results in the patient's ability to return to previous function and resumption of normal activities. 2. Treatment of a chronic wound with standard of care and autologous platelet rich plasma (PRP) will result in complete wound healing within twenty weeks, whereas complete wound healing will not be observed within twenty weeks in patients receiving standard wound care only (Control Group).
Interventions
DEVICEAutologous PRP Gel
Autologous PRP Gel is prepared using the Arteriocyte Magellan® System (510(k) approved), an Autologous Platelet Separator Instrument, which is a microprocessor-controlled centrifuge designed to be used in the clinical laboratory or intraoperatively at point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood. The Arteriocyte Magellan® automatically and quickly separates PRP from anticoagulated blood and dispenses it into a separate sterile syringe. The prepared PRP is then activated (by mixing with thrombin and calcium chloride) and sprayed directly on the area to be treated.
DEVICEAutologous PRP Injections
Autologous PRP Gel is prepared using the Arteriocyte Magellan® System (510(k) approved), an Autologous Platelet Separator Instrument, which is a microprocessor-controlled centrifuge designed to be used in the clinical laboratory or intraoperatively at point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood. The Arteriocyte Magellan® automatically and quickly separates PRP from anticoagulated blood and dispenses it into a separate sterile syringe. The prepared PRP is then drawn into multiple small syringes and injected directly into the wound bed or the skin surrounding it.
DEVICEAutologous PRP Gel plus PRP Injections
Autologous PRP Gel is prepared using the Arteriocyte Magellan® System (510(k) approved), an Autologous Platelet Separator Instrument, which is a microprocessor-controlled centrifuge designed to be used in the clinical laboratory or intraoperatively at point of care for the safe and rapid preparation of platelet poor plasma and PRP from a small sample of blood. The Arteriocyte Magellan® automatically and quickly separates PRP from anticoagulated blood and dispenses it into a separate sterile syringe. The prepared PRP is then divided into equal parts and half is drawn into multiple small syringes and injected directly into the skin surrounding the wound bed, half is activated (by mixing with thrombin and calcium chloride) and sprayed the wound bed.
PROCEDUREStandard Wound Care
Subjects in the control group will receive Standard Wound Care treatment for chronic wounds according to accepted medical practices.
Sponsors
Arteriocyte, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Medicare Eligible * Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to screening activities * Male or female ≥ 18 years of age * Duration of Diabetic Foot Ulcers (DFU),Venous Ulcers (VU), or Pressure Ulcers (PU) is greater than 30 days at first visit/subject screening * DFU is classified as Wagner 1 -2 on the Wagner classification system * If more than one non-healing wound is present, the largest of the wounds that is classified as a Wagner 1 - 2. * If a subject has multiple eligible wounds, the largest wound will be selected. There must be at least 4 cm between the index wound and other wounds; if all wounds are closer than 4 cm, the subject should not be enrolled (screen failure). * The ulcer must be clinically non-infected * Able and willing to comply with the procedures required by the protocol. Subjects may be managed as either inpatient or outpatient. * If a female of childbearing potential, the subject must have a negative urine pregnancy test at screening and must agree to use adequate contraception methods for the duration of the study. * Ankle Brachial Index (ABI) greater than or equal to 0.7.
Exclusion criteria
* Subjects with known sensitivity to components of the Arteriocyte BioBandage™ (calcium chloride, thrombin, acid citrate dextrose solution A (ACDA)). * Current treatment of another chronic wound in the same limb (defined as arm or leg). * Wound is not of DFU, PU, or VU pathophysiology. * PU is classified as late stage III or stage IV. * Confirmed presence of osteomyelitis, or if osteomyelitis is suspected. * Received systemic corticosteroids or immunosuppressive agents, hyperbaric oxygen therapy (HBOT), electrostimulation, growth factors, or any cell or tissue-derived products for wounds during the 30 days preceding the screening visit. * Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study. * Received radiation therapy or chemotherapy within previous 6 months. * Any malignancy other than non-melanoma skin cancer. * Patient has radiographic evidence consistent with diagnosis of neuropathic osteoarthropathy (Charcot foot) in the treatment limb. * Ulcer area decreases by greater than or equal to 30% during screening period * Subjects who are cognitively impaired and do not have a healthcare proxy. * Subject has inadequate venous access for repeated blood draw required for PRP preparation. * Subject has sickle cell anemia. * Subject is pregnant or plans to become pregnant during the duration of the trial. * Concurrent participation in a clinical trial in which an investigational agent is used. * Females who are nursing. * Subjects with Thrombocytopenia \< 100,000 platelets/µL.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Size | 16 Weeks | Wound size will be measured with ruler/probe for length, width and depth as well as with digital imaging. Wound size will be assessed in digital images taken of the wound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of wound closure (change in wound size over time) | 16 weeks | The ratio of wound percent change over time will be used |
| Complete wound healing | 16 weeks | Complete wound healing is determined when the wound shows no sign of drainage for two consecutive visits (over two weeks) |
| Health Related Quality of Life | 16 weeks | The Center for Disease Control (CDC) Health Related Quality of Life (HRQoL)-14, Healthy Days Measure will be administered |
| Wound recurrence | 16 weeks | Incidence of wound recurrence over the course of 16 weeks |
Countries
United States
Outcome results
None listed