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

NCT02071979 | Terminated

• 2 other identifiers: ART-13-006CAG-00190R3
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 6

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.

Conditions

Diabetic Foot Ulcers; Venous Ulcers; Pressure Ulcers

Keywords

Chronic; Non-healing; Wounds

Outcome Measures

Primary Outcomes (1)

• Wound Size

  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.

  16 Weeks

Secondary Outcomes (4)

• Rate of wound closure (change in wound size over time)

  16 weeks

• Complete wound healing

  16 weeks

• Health Related Quality of Life

  16 weeks

• Wound recurrence

  16 weeks

Study Arms (4)

Autologous PRP Gel

EXPERIMENTAL

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.

Device: Autologous PRP Gel; Procedure: Standard Wound Care

Autologous PRP Injections

EXPERIMENTAL

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.

Device: Autologous PRP Injections; Procedure: Standard Wound Care

Autologous PRP Gel plus PRP Injections

EXPERIMENTAL

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.

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

Standard Wound Care

NO INTERVENTION

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

Interventions

Autologous PRP Gel DEVICE

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.

Autologous PRP Gel; Autologous PRP Gel plus PRP Injections

Autologous PRP Injections DEVICE

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.

Autologous PRP Gel plus PRP Injections; Autologous PRP Injections

Autologous PRP Gel plus PRP Injections DEVICE

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.

Autologous PRP Gel plus PRP Injections

Standard Wound Care PROCEDURE

Subjects in the control group will receive Standard Wound Care treatment for chronic wounds according to accepted medical practices.

Autologous PRP Gel; Autologous PRP Gel plus PRP Injections; Autologous PRP Injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arteriocyte, Inc.: lead

Study Sites (6)

Good Samaritan Wound Care Center

Bakersfield, California, 93313, United States

Location

Sunnyside Foot and Ankle

Idaho Falls, Idaho, 83404, United States

Location

Wound Care Center, Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Comprehensive Wound Healing Center and Hyperbarics

Lake Success, New York, 11042, United States

Location

Total Foot Care

Cleveland, Ohio, 44107, United States

Location

Heritage Valley Health System

Beaver, Pennsylvania, 15009, United States

Location

Related Publications (8)

• 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.

  PMID: 16799373 BACKGROUND

• 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.

  PMID: 23076929 BACKGROUND

• Lacci KM, Dardik A. Platelet-rich plasma: support for its use in wound healing. Yale J Biol Med. 2010 Mar;83(1):1-9.

  PMID: 20351977 BACKGROUND

• 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.

  PMID: 15062754 BACKGROUND

• 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.

  PMID: 15225241 BACKGROUND

• 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.

  PMID: 23509083 BACKGROUND

• 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.

  PMID: 21847007 BACKGROUND

• 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.

  PMID: 16799184 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Pressure Ulcer; Bronchiolitis Obliterans Syndrome; Wounds and Injuries

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Brittany Hamilton

  Compass Biomedical (Formerly Arteriocyte, Inc.)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 26, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2018
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

US (6)