Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds
This study will examine differences in the process of wound-healing in patients treated with a gel made from platelet rich plasma (a concentration of proteins derived from a patients own blood) 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.
Study Start Date
Estimated Completion Date
- Device: Autologous PRP Injections
- Procedure: Standard Wound Care
- Device: Autologous PRP Gel plus PRP Injections
- Device: Autologous PRP Gel
- Surgery: Wound Healing
- Endocrinology: Diabetes
- Dermatology: Dermatopathology
- Autologous PRP Gel
- Diabetic Foot
- Pressure Ulcer
- Varicose Ulcer
Arteriocyte, Inc. -- ART-13-006
Observational [Patient Registry]
- Medicare Eligible
- Written informed consent obtained from either the patient or the patient'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/patient screening
- 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
- If a patient 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 patient should not be enrolled (screen failure).
- The ulcer must be clinically non-infected (culture assessment during patient eligibility screening)
- Able and willing to comply with the procedures required by the protocol. Patients may be managed as either inpatient or outpatient.
- If a female of childbearing potential, the patient must have a negative serum pregnancy test at screening.
- Patients with known sensitivity to components of the Arteriocyte PRP kit (calcium chloride, thrombin, acid citrate dextrose solution A (ACDA)).
- Current treatment of another chronic wound in the same limb.
- Wound is not of DFU, Pressure ulcer or venostasis ulcer pathophysiology.
- 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.
- 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).
- Patients who are cognitively impaired and do not have a healthcare proxy.
- Serum albumin of less than 2.5 g/dL.
- Patient has inadequate venous access for repeated blood draw required for PRP preparation.
- Patient has sickle cell anemia.
- Patient is pregnant or plans to become pregnant during the duration of the trial.
- Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study.
- Concurrent participation in a clinical trial in which an investigational agent is used.
- Females who are pregnant or nursing or intend to become pregnant during the duration of the study.
- Patients with Thrombocytopenia < 100,000 platelets/µL.
18 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (4)
|Comprehensive Wound Healing Center and Hyperbarics - Lake Success, New York||39.6 miles||None||None||None|
|Wound Care Center Englewood Hospital and Medical Center - Englewood, New Jersey||44.0 miles||Neha Kalra||201-608-2107||NehaKalra@EHMCHealth.org|
|Heritage Valley Health System - Beaver, Pennsylvania||373.2 miles||None||None||None|
|Total Foot Care - Cleveland, Ohio||444.4 miles||None||None||None|