Safety and Efficacy Study of APIC-PRP in Non-healing Diabetic Foot Ulcers

August 4, 2014 updated by: Cytonics Corporation

A Multi-Center, Randomized Trial Comparing the Effectiveness of APIC-PRP to Control, When Added to Standard of Care in the Treatment of Non-healing Diabetic Foot Ulcers

Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with physician-selected standard of care treatment such as debridement, hydrogel or saline irrigation, primary dressing, and offloading will be randomized into one of two groups, the Standard of Care (SoC) or APIC-PRP + SoC. APIC-PRP has high level of platelets that produce growth factors that can help in wound healing.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
274

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Prior to the first clinical intervention, a signed Informed Consent Form (ICF) and Data Consent Form (DCF) must be obtained from the subject or legal representative
  • Diagnosed with insulin-dependent or non-insulin-dependent diabetes (Type I or II, respectively), requiring medical treatment as determined by the physician
  • Subjects will have only one diabetic foot ulcer on the target limb (referred to as the Index Ulcer)
  • The Index Ulcer, classified using the University of Texas Wound Classification System (Appendix 7), is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces)
  • Debrided ulcer size between 1 cm2 and 4 cm2. See Appendix 3 for instructions on wound area measurement
  • DFU with a duration ≥ 1 month at first visit
  • The target ulcer is free of clinical signs of infection, identified by inflammation (redness, warmth, swelling, tenderness, or pain) or purulent exudates (Lipsky et al, 2012).
  • The patient meets Medicare/Medicaid eligibility requirements. Subject's ulcer extends through the dermis and into subcutaneous tissue (granulation tissue may be present) but without exposure of muscle, tendon, bone or joint capsule.
  • Post-debridement, subject's wound is free of necrotic debris and appears to be made up of healthy vascularized tissue.
  • Demonstrated adequate offloading regimen.
  • Subject has adequate circulation to the study foot as evidenced by a Doppler measured ankle-bronchial index (ABI) of ≥ 0.7 after 10 minutes of rest
  • Age >18 years old at the time the informed consent is signed
  • Female subjects must have a negative urine pregnancy test prior to the first treatment
  • Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician

Exclusion Criteria:

  • Subject has inadequate venous access the blood draw required for APIC-PRP Administration. Subjects with PIC or IV access are preferred.
  • Hemoglobin of less than 12 g/dL
  • Inadequate amount of blood drawn to produce sufficient APIC-PRP. One complete APIC-PRP preparation requires 114ml of blood drawn per APIC-PRP preparation.
  • Subject's ulcer has increased in size by >50% during the run-in Screening period.
  • If the subject's ulcer healed by 25% or more during the run-in Screening period they will be excluded.
  • Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by APIC-PRP (malignancy in nearby wound)
  • Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
  • The target ulcer demonstrates underlying osteomyelitis, defined as infection in the bone, identified by Fever, chills, or pain in the infected bone. Any exposed bone will be classified as osteomyelitis.
  • Subject has a history of bleeding disorder.
  • Any malignancy other than non-melanoma skin cancer requiring treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or corticosteroids less than 30 days before enrolment.
  • Subject has gangrene present on any part of the affected limb. Subject's ulcer is over a Charcot deformity of the mid-foot ("Rocker-Bottom Foot") or over the tarsal bones-talus, distal calcaneus, navicular, and cuboid.
  • Subject's ulcer has tunnels or sinus tracts that cannot be completely debrided.
  • Subject has severe malnutrition as evidenced by albumin < 2.5 g/dL. A previous serum albumin test that is <6 weeks old is sufficient for this criteria.
  • Subject has Acquired Immunodeficiency Syndrome (AIDS), liver disease, aplastic anemia, scleroderma, malignancy, cellulitis, suspected osteomyelitis or other evidence of systemic infection, or is Human Immunodeficiency Virus (HIV)-positive.
  • Subject has any elective osseous procedures to the study foot within 30 days prior to the Initial Visit.
  • Subject is on dialysis.
  • Subjects who are cognitively impaired and therefore can not give consent, and do not have a healthcare proxy
  • Subjects who, in the opinion of the Investigator, represent poor medical, psychological or psychiatric risks for whom therapy with an investigational product would be unwise.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: APIC-PRP and Standard of Care
APIC-PRP
Device: APIC-PRP
APIC-PRP
Placebo Comparator: Placebo, Saline plus standard of care
Other: Placebo, Saline plus standard of care
Placebo, Saline plus standard of care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete wound closure within 12 weeks
Time Frame: 12 weeks
The primary outcome expected for this study is an increase in the proportion of DFUs that have exhibited complete closure within 12 weeks between the APIC-PRP + SoC groups and SoC alone groups.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement in wound healing trajectory within 12 weeks
Time Frame: 12 weeks
The secondary outcome expected for this study is an improvement in wound healing trajectory of DFUs over the 12 weeks treatment period between the APIC-PRP + SoC groups and SoC alone groups.
12 weeks
Improvement in wound healing for the patient to return to function over the 12 weeks
Time Frame: 12 weeks
The secondary outcome expected for this study is an improvement in wound healing for the patient to return to function over the 12 weeks treatment period between the APIC-PRP + SoC groups and SoC alone groups.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cytonics Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gaetano J Scuderi, MD, Cytonics Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Cyt201-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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