Back to resultsRegistry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds (CMS)
Primary Purpose
Diabetic Foot Ulcers, Venous Ulcers, Pressure Ulcers
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Autologous PRP Gel
Autologous PRP Injections
Autologous PRP Gel plus PRP Injections
Standard Wound Care
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring Chronic, Non-healing, Wounds
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.
Sites / Locations
- Good Samaritan Wound Care Center
- Sunnyside Foot and Ankle
- Wound Care Center, Englewood Hospital and Medical Center
- Comprehensive Wound Healing Center and Hyperbarics
- Total Foot Care
- Heritage Valley Health System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Autologous PRP Gel
Autologous PRP Injections
Autologous PRP Gel plus PRP Injections
Standard Wound Care
Arm 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.
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.
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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rate of wound closure (change in wound size over time)
The ratio of wound percent change over time will be used
Complete wound healing
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
The Center for Disease Control (CDC) Health Related Quality of Life (HRQoL)-14, "Healthy Days Measure" will be administered
Wound recurrence
Incidence of wound recurrence over the course of 16 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02071979
Brief Title
Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds
Acronym
CMS
Official Title
Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Skin Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arteriocyte, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers, Venous Ulcers, Pressure Ulcers
Keywords
Chronic, Non-healing, Wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Autologous PRP Gel
Arm Type
Experimental
Arm 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.
Arm Title
Autologous PRP Injections
Arm Type
Experimental
Arm 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.
Arm Title
Autologous PRP Gel plus PRP Injections
Arm Type
Experimental
Arm 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.
Arm Title
Standard Wound Care
Arm Type
No Intervention
Arm 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
Intervention Type
Device
Intervention Name(s)
Autologous PRP Gel
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Autologous PRP Injections
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Autologous PRP Gel plus PRP Injections
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard Wound Care
Intervention Description
Subjects in the control group will receive Standard Wound Care treatment for chronic wounds according to accepted medical practices.
Primary Outcome Measure Information:
Title
Wound Size
Description
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.
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Rate of wound closure (change in wound size over time)
Description
The ratio of wound percent change over time will be used
Time Frame
16 weeks
Title
Complete wound healing
Description
Complete wound healing is determined when the wound shows no sign of drainage for two consecutive visits (over two weeks)
Time Frame
16 weeks
Title
Health Related Quality of Life
Description
The Center for Disease Control (CDC) Health Related Quality of Life (HRQoL)-14, "Healthy Days Measure" will be administered
Time Frame
16 weeks
Title
Wound recurrence
Description
Incidence of wound recurrence over the course of 16 weeks
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brittany Hamilton
Organizational Affiliation
Compass Biomedical (Formerly Arteriocyte, Inc.)
Official's Role
Study Director
Facility Information:
Facility Name
Good Samaritan Wound Care Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93313
Country
United States
Facility Name
Sunnyside Foot and Ankle
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Wound Care Center, Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Comprehensive Wound Healing Center and Hyperbarics
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Total Foot Care
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44107
Country
United States
Facility Name
Heritage Valley Health System
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16799373
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.
Results Reference
background
PubMed Identifier
23076929
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.
Results Reference
background
PubMed Identifier
20351977
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.
Results Reference
background
PubMed Identifier
15062754
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.
Results Reference
background
PubMed Identifier
15225241
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.
Results Reference
background
PubMed Identifier
23509083
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.
Results Reference
background
PubMed Identifier
21847007
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.
Results Reference
background
PubMed Identifier
16799184
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.
Results Reference
background
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Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds
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