Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds (CMS)

Arteriocyte Medical Systems

Status: Terminated

Conditions: Venous Ulcers; Diabetic Foot Ulcers; Pressure Ulcers

Treatments: Device: Autologous PRP Injections; Device: Autologous PRP Gel; Device: Autologous PRP Gel plus PRP Injections; Procedure: Standard Wound Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT02071979

ART-13-006

CAG-00190R3 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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1,500 participants in 4 patient groups

Autologous PRP Gel

Experimental group

Description:

The method of application for PRP treatment will be decided by the clinician in accordance with the appearance of the wound bed. The application of topical PRP gel may be used in chronic wounds possessing an open, moist wound bed according to following treatment schedule: Baseline/Week 0, Week 1, Week 2, Week 3, Week 7, and Week 11. The Arteriocyte Magellan® System (510(k) cleared) will be used to prepare the autologous PRP gel. For data analysis, the data from these patients will be classified as PRP Treatment Group (Topical application) data.

Treatment:

Procedure: Standard Wound Care

Device: Autologous PRP Gel

Autologous PRP Injections

Experimental group

Description:

The method of application for PRP treatment will be decided by the clinician in accordance with the appearance of the wound bed. Autologous PRP Injections may be used where chronic wounds possess a raised, hyperproliferative wound margin and/or plaque, according to following treatment schedule: Baseline/Week 0, Week 1, Week 2, Week 3, Week 7, and Week 11. The Arteriocyte Magellan® System (510(k) cleared) will be used to prepare Autologous PRP for injections. For data analysis, the data from these patients will be classified as PRP Treatment Group (Direct Injection) data.

Treatment:

Device: Autologous PRP Injections

Procedure: Standard Wound Care

Autologous PRP Gel plus PRP Injections

Experimental group

Description:

The method of application for PRP treatment will be decided by the clinician in accordance with the appearance of the wound bed. Some wounds may be suitable for both Autologous PRP Gel plus PRP Injections. Autologous PRP injections into, or to the periphery of, a moist wound bed in which no scarification or raised wound margin is apparent (where autologous PRP Gel can also be used) may further augment wound healing by addressing wound healing in multiple areas, following the treatment schedule: Baseline/Week 0, Week 1, Week 2, Week 3, Week 7, and Week 11. The Arteriocyte Magellan® System (510(k) cleared) will be used to prepare the autologous PRP gel. For data analysis, the data from these patients will be classified as PRP Treatment Group (Topical and Direct) data.

Treatment:

Device: Autologous PRP Injections

Procedure: Standard Wound Care

Device: Autologous PRP Gel plus PRP Injections

Device: Autologous PRP Gel

Standard Wound Care

No Intervention group

Description:

Subjects in the control group will receive Standard Wound Care treatment for chronic wounds according to accepted medical practices. For data analysis, the data from these patients will be classified as Control (Standard of Care) Group data