Diabetic Foot UlcersNCT02312596
A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Non-Healing Diabetic Foot Ulcers
A study testing PRP Concepts Fibrin Bio-Matrix and Usual and Customary Practice in people with Diabetic Foot Ulcers, run by PRP Concepts, LLC at 1 site in United States.
Trial summary
A prospective, randomized, controlled, clinical study to establish clinical based evidence of PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- PRP Concepts Fibrin Bio-Matrix and Usual and Customary Practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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
- A full thickness diabetic foot ulcer with a viable wound bed
- Diabetes mellitus (type I or II) that is adequately controlled
- The ulcer is greater than 4 weeks duration.
- The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (index ulcer) is a Wagner 1 or 2 DFU (see Appendix for Wagner Classification) that is located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces but not on the heel).
- Post-debridement, the ulcer size must be between 0.5 - 20 cm2.
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- One of the following assessments was completed to confirm pedal circulation: ankle / brachial index is between 0.7 to 1.2; transcutaneous partial pressure oxygen (TcPO2) > 30 mmHg at the ankle; or toe pressure of >40mm Hg or a doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
- Able and willing to provide a voluntary written informed consent.
- Able and willing to wear an off-loading device or orthopedic shoe
- Able and willing to attend scheduled follow-up visits and study related exams
Who cannot join
- Greater than 30% reduction in wound size during the first two weeks of observation and treatment by the investigator
- Wagner 3, 4, 5 DFU
- Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis
- Wounds that are likely to require dressing changes more frequent than twice weekly (heavy exudates).
- Known allergy tor sensitivity to Eclipse PRP kit components (calcium chloride, calcium gluconate or acid citrate dextrose solution A (ACDA))
- Presence of Gangrene
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- Active Charcot's disease as determined by clinical and radiographic examination of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers)
- Malignancy at or near the ulcer site
- Known serum albumin < 2.5 mg/dl, Known renal failure as determined by a Creatinine > 2.5 mg/dl, Plasma Platelet count of less than 100 x 109/L, Hemoglobin of less than 10.5 g/dL
- Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV
- Severe liver disease. Severe liver disease is defined as known history of chronic hepatitis or cirrhosis \&/or the following abnormal Liver Function Tests: ALT \& AST >35, ALP >120, PT >12 seconds.
- Presence of additional abnormal lab values obtained within 7 days prior to the Day 0 visit determined to be clinically significant by the investigator including: WBC >13,000/cm3 or < 5, 000 cm3, or electrolytes that are outside the host institution's range of normal.
- Radiation therapy, chemotherapy, chronic steroid use or immunosuppressive therapy within 30 days of enrollment
- Received another investigational device or drug within 30 days of enrollment
- Received allograft, autograft or xenograft within 30 days of enrollment
- Subject has inadequate venous access for repeated blood draw required for Eclipse RPR administrations
- Subject requires or is anticipated to require interventions directed at improvement of arterial perfusion to affected area.
- Ulcer expected to be treated with any advanced therapeutics (e.g., HBOT)
- Any condition judged by the investigator that would cause the study to be detrimental to the subject
- Alcohol or drug abuse, defined as current medical treatment for substance abuse
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Westchester General Hospital
Miami, Florida, 33155
Jose D Suarez, MD, 305-264-5252 ext. 2200, drjdsuarez@westchesterhospital.com
Gerardo Masferrer, MA, MS, PhD, 305-264-5252 ext. 6200, gerardo.masferrer@westchesterhospital.com
About this study
A prospective, randomized, controlled, clinical study to establish clinical based evidence of PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs.
Read the detailed description
This is a prospective, randomized, single-blind, controlled, multi-center study for subjects undergoing DFU treatment. Qualified subjects will be randomized (1:1); test group (PRP Concepts Fibrin Bio-Matrix) and control group (usual and customary practice). The study will consist of 3 periods: a screening period, an active treatment period, and a follow-up period (if healed). Approximately 250 subjects will be enrolled. Subjects will be ≥18 years of age with a chronic Wagner grade 1 or 2 DFU (greater than 1 month duration). Each subject will be enrolled in the active treatment period for up to 12 weeks, or to closure of wound with a confirmatory visit 2 weeks after wound closure, whether such closure occurs at 12 weeks or earlier.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- PRP Concepts Fibrin Bio-Matrix, Usual and Customary Practice
- Keywords
- non-healing wound, diabetic foot ulcer, platelet rich plasma
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP Concepts Fibrin Bio-MatrixDevice
Application of PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice
Usual and Customary PracticeOther
Also called Standard of Care
Usual and customary care for non-healing wounds
| Study group | Role | What they receive |
|---|---|---|
| PRP Concepts Fibrin Bio-Matrix | Experimental | PRP Concepts Fibrin Bio-Matrix Receives: Device: PRP Concepts Fibrin Bio-Matrix; Other: Usual and Customary Practice |
| Usual and customary practice | Active comparator | Usual and customary practice Receives: Other: Usual and Customary Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete wound closure
Complete wound closure is defined as full epithelialization of the wound with the absence of drainage, durability confirmed at 2 weeks
Measured: 12 weeks
Percent of wounds healed
Percentage of closure of the wound
Measured: 12 weeks
Secondary outcomes (3)
Wound Trajectory
Mean of percent (%) wound size changes at 4 weeks, 8 weeks and 12 weeks
Measured: 4, 8, 12 weeks
Ulcer Recurrence
Ulcer recurrence out to 3 months for subjects whose wounds heal by conclusion of 12 week visit.
Measured: 3 months
Quality of Life score
Changes in Quality of Life scores and ability to return to previous function/resumption of normal activities
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study start1 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PRP Concepts, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Damon Keeley, Study director, PRP Concepts, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312596
- Sponsor's protocol ID
- PC002
- Status last verified
- Apr 2021
- First submitted
- 5 Dec 2014
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Non-Healing Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02312596
- Acronym / sponsor ID
- PC002
- Conditions
- Diabetic Foot Ulcers
- Keywords
- non-healing wound, diabetic foot ulcer, platelet rich plasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- PRP Concepts, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Dec 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.
A prospective, randomized, controlled, clinical study to establish clinical based evidence of PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs.
Detailed description
This is a prospective, randomized, single-blind, controlled, multi-center study for subjects undergoing DFU treatment. Qualified subjects will be randomized (1:1); test group (PRP Concepts Fibrin Bio-Matrix) and control group (usual and customary practice). The study will consist of 3 periods: a screening period, an active treatment period, and a follow-up period (if healed). Approximately 250 subjects will be enrolled. Subjects will be ≥18 years of age with a chronic Wagner grade 1 or 2 DFU (greater than 1 month duration). Each subject will be enrolled in the active treatment period for up to 12 weeks, or to closure of wound with a confirmatory visit 2 weeks after wound closure, whether such closure occurs at 12 weeks or earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP Concepts Fibrin Bio-Matrix | Experimental | Device: PRP Concepts Fibrin Bio-Matrix, Other: Usual and Customary PracticePRP Concepts Fibrin Bio-Matrix |
| Usual and customary practice | Active comparator | Other: Usual and Customary PracticeUsual and customary practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Medicare eligible
- A full thickness diabetic foot ulcer with a viable wound bed
- Diabetes mellitus (type I or II) that is adequately controlled
- The ulcer is greater than 4 weeks duration.
- The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (index ulcer) is a Wagner 1 or 2 DFU (see Appendix for Wagner Classification) that is located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces but not on the heel).
Key exclusion criteria (21 listed)
- Greater than 30% reduction in wound size during the first two weeks of observation and treatment by the investigator
- Wagner 3, 4, 5 DFU
- Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis
- Wounds that are likely to require dressing changes more frequent than twice weekly (heavy exudates).
- Known allergy tor sensitivity to Eclipse PRP kit components (calcium chloride, calcium gluconate or acid citrate dextrose solution A (ACDA))
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 |
|---|---|---|
| PRP Concepts Fibrin Bio-MatrixApplication of PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice | Device | PRP Concepts Fibrin Bio-Matrix |
| Usual and Customary PracticeAlso: Standard of CareUsual and customary care for non-healing wounds | Other | PRP Concepts Fibrin Bio-Matrix, Usual and customary practice |
Primary outcome
Time to complete wound closure
Time frame: 12 weeks
Complete wound closure is defined as full epithelialization of the wound with the absence of drainage, durability confirmed at 2 weeks
Percent of wounds healed
Time frame: 12 weeks
Percentage of closure of the wound
3 secondary outcomes
Wound Trajectory
Time frame: 4, 8, 12 weeks
Ulcer Recurrence
Time frame: 3 months
Quality of Life score
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Damon Keeley study director
PRP Concepts, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP Concepts Fibrin Bio-Matrix and Usual and Customary Practice in people with Diabetic Foot Ulcers, run by PRP Concepts, LLC at 1 site 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 10 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damon Keeley (732-530-2885, damon@prpconcepts.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete wound closure (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2021.