Diabetic Foot UlcersCMSNCT02071979
Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds
A study testing Autologous PRP Gel, Autologous PRP Injections and Autologous PRP Gel plus PRP Injections in people with Diabetic Foot Ulcers and Venous Ulcers, run by Arteriocyte, Inc. at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers, Venous Ulcers, Pressure Ulcers
- What is being tested?
- Autologous PRP Gel, Autologous PRP Injections and Autologous PRP Gel plus PRP Injections
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2014to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Good Samaritan Wound Care Center
Bakersfield, California, 93313
Heritage Valley Health System
Beaver, Pennsylvania, 15009
Total Foot Care
Cleveland, Ohio, 44107
Wound Care Center, Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Sunnyside Foot and Ankle
Idaho Falls, Idaho, 83404
Comprehensive Wound Healing Center and Hyperbarics
Lake Success, New York, 11042
About this study
Official title: Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Skin Wounds
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.
Read the 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).
- Conditions
- Diabetic Foot Ulcers, Venous Ulcers, Pressure Ulcers
- Being tested
- Autologous PRP Gel, Autologous PRP Injections, Autologous PRP Gel plus PRP Injections, Standard Wound Care
- Keywords
- Chronic, Non-healing, Wounds
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer, Bronchiolitis Obliterans Syndrome, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous PRP GelDevice
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 InjectionsDevice
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 InjectionsDevice
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.
Standard Wound CareProcedure or surgery
Subjects in the control group will receive Standard Wound Care treatment for chronic wounds according to accepted medical practices.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 Weeks
Secondary outcomes (4)
Rate of wound closure (change in wound size over time)
The ratio of wound percent change over time will be used
Measured: 16 weeks
Complete wound healing
Complete wound healing is determined when the wound shows no sign of drainage for two consecutive visits (over two weeks)
Measured: 16 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
Measured: 16 weeks
Wound recurrence
Incidence of wound recurrence over the course of 16 weeks
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arteriocyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brittany Hamilton, Study director, Compass Biomedical (Formerly Arteriocyte, Inc.)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071979
- Sponsor's protocol ID
- ART-13-006
- Other IDs
- CAG-00190R3
- Acronym
- CMS
- Status last verified
- Jan 2018
- First submitted
- 20 Feb 2014
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16799373Martinez-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.
PubMed 23076929Lacci KM, Dardik A. Platelet-rich plasma: support for its use in wound healing. Yale J Biol Med. 2010 Mar;83(1):1-9.
PubMed 20351977Crovetti 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.
PubMed 15062754Mazzucco 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.
PubMed 15225241Shan 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.
PubMed 23509083Yang 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.
PubMed 21847007Driver 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.
PubMed 16799184
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Skin Wounds
- ClinicalTrials.gov ID
- NCT02071979
- Acronym / sponsor ID
- CMS / ART-13-006
- Conditions
- Diabetic Foot Ulcers, Venous Ulcers, Pressure Ulcers
- Keywords
- Chronic, Non-healing, Wounds
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Arteriocyte, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jan 2018 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Autologous PRP Gel | Experimental | Device: Autologous PRP Gel, Procedure: Standard Wound CareThe 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. |
| Autologous PRP Injections | Experimental | Device: Autologous PRP Injections, Procedure: Standard Wound CareThe 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. |
| Autologous PRP Gel plus PRP Injections | Experimental | Device: Autologous PRP Gel, Device: Autologous PRP Injections, Device: Autologous PRP Gel plus PRP Injections, Procedure: Standard Wound CareThe 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous PRP GelAutologous 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. | Device | Autologous PRP Gel, Autologous PRP Gel plus PRP Injections |
| Autologous PRP InjectionsAutologous 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. | Device | Autologous PRP Gel plus PRP Injections, Autologous PRP Injections |
| Autologous PRP Gel plus PRP InjectionsAutologous 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. | Device | Autologous PRP Gel plus PRP Injections |
| Standard Wound CareSubjects in the control group will receive Standard Wound Care treatment for chronic wounds according to accepted medical practices. | Procedure or surgery | Autologous PRP Gel, Autologous PRP Gel plus PRP Injections, Autologous PRP Injections |
Primary outcome
Wound Size
Time frame: 16 Weeks
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.
4 secondary outcomes
Rate of wound closure (change in wound size over time)
Time frame: 16 weeks
Complete wound healing
Time frame: 16 weeks
Health Related Quality of Life
Time frame: 16 weeks
Wound recurrence
Time frame: 16 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Background: PubMed 16799373Mustoe 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.
- Background: PubMed 23076929Martinez-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.
- Background: PubMed 20351977Lacci KM, Dardik A. Platelet-rich plasma: support for its use in wound healing. Yale J Biol Med. 2010 Mar;83(1):1-9.
- Background: PubMed 15062754Crovetti 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.
- Background: PubMed 15225241Mazzucco 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.
- Background: PubMed 23509083Shan 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.
- Background: PubMed 21847007Yang 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.
- Background: PubMed 16799184Driver 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brittany Hamilton study director
Compass Biomedical (Formerly Arteriocyte, Inc.)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous PRP Gel, Autologous PRP Injections and Autologous PRP Gel plus PRP Injections in people with Diabetic Foot Ulcers and Venous Ulcers, run by Arteriocyte, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Size (time frame: 16 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02071979, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.