Clinical trial NCT02071979: Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds
Official title: Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Skin Wounds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot Ulcers
Venous Ulcers
Pressure Ulcers
Keywords: Chronic
Non-healing
Wounds
Lead sponsor: Arteriocyte, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Wound Size
timeFrame: 16 Weeks
Secondary outcomes:
measure: Rate of wound closure (change in wound size over time)
timeFrame: 16 weeks
measure: Complete wound healing
timeFrame: 16 weeks
measure: Health Related Quality of Life
timeFrame: 16 weeks
measure: Wound recurrence
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Good Samaritan Wound Care Center
state: California
city: Idaho Falls
country: United States
facility: Sunnyside Foot and Ankle
state: Idaho
city: Englewood
country: United States
facility: Wound Care Center, Englewood Hospital and Medical Center
state: New Jersey
city: Lake Success
country: United States
facility: Comprehensive Wound Healing Center and Hyperbarics
state: New York
city: Cleveland
country: United States
facility: Total Foot Care
state: Ohio
city: Beaver
country: United States
facility: Heritage Valley Health System
state: Pennsylvania
Study officials:
affiliation: Compass Biomedical (Formerly Arteriocyte, Inc.)
name: Brittany Hamilton
role: STUDY_DIRECTOR
References:
citation: Mustoe TA, O'Shaughnessy K, Kloeters O. Chronic wound pathogenesis and current treatment strategies: a unifying hypothesis. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):35S-41S. doi: 10.1097/01.prs.0000225431.63010.1b.
citation: Martinez-Zapata MJ, Marti-Carvajal AJ, Sola I, Exposito JA, Bolibar I, Rodriguez L, Garcia J. Autologous platelet-rich plasma for treating chronic wounds. Cochrane Database Syst Rev. 2012 Oct 17;10:CD006899. doi: 10.1002/14651858.CD006899.pub2.
citation: Lacci KM, Dardik A. Platelet-rich plasma: support for its use in wound healing. Yale J Biol Med. 2010 Mar;83(1):1-9.
citation: Crovetti G, Martinelli G, Issi M, Barone M, Guizzardi M, Campanati B, Moroni M, Carabelli A. Platelet gel for healing cutaneous chronic wounds. Transfus Apher Sci. 2004 Apr;30(2):145-51. doi: 10.1016/j.transci.2004.01.004.
citation: Mazzucco L, Medici D, Serra M, Panizza R, Rivara G, Orecchia S, Libener R, Cattana E, Levis A, Betta PG, Borzini P. The use of autologous platelet gel to treat difficult-to-heal wounds: a pilot study. Transfusion. 2004 Jul;44(7):1013-8. doi: 10.1111/j.1537-2995.2004.03366.x.
citation: Shan GQ, Zhang YN, Ma J, Li YH, Zuo DM, Qiu JL, Cheng B, Chen ZL. Evaluation of the effects of homologous platelet gel on healing lower extremity wounds in patients with diabetes. Int J Low Extrem Wounds. 2013 Mar;12(1):22-9. doi: 10.1177/1534734613477113.
citation: Yang HS, Shin J, Bhang SH, Shin JY, Park J, Im GI, Kim CS, Kim BS. Enhanced skin wound healing by a sustained release of growth factors contained in platelet-rich plasma. Exp Mol Med. 2011 Nov 30;43(11):622-9. doi: 10.3858/emm.2011.43.11.070.
citation: Driver VR, Hanft J, Fylling CP, Beriou JM; Autologel Diabetic Foot Ulcer Study Group. A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. Ostomy Wound Manage. 2006 Jun;52(6):68-70, 72, 74 passim.