Diabetic Foot UlcerNCT02209662
Safety and Efficacy Study of APIC-PRP in Non-healing Diabetic Foot Ulcers
A study testing APIC-PRP in people with Diabetic Foot Ulcer, run by Cytonics Corporation.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- APIC-PRP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2015
- 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
- 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
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- 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
Who cannot join
- 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)
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- 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.
About this study
Official title: 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- APIC-PRP, Placebo, Saline plus standard of care
- Keywords
- APIC-PRP, Chronic Wounds, Diabetic foot ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APIC-PRPDevice
APIC-PRP
Placebo, Saline plus standard of careOther
Placebo, Saline plus standard of care
| Study group | Role | What they receive |
|---|---|---|
| APIC-PRP and Standard of Care | Experimental | APIC-PRP Receives: Device: APIC-PRP |
| Placebo, Saline plus standard of care | Placebo comparator | Placebo, Saline plus standard of care Receives: Other: Placebo, Saline plus standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete wound closure within 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.
Measured: 12 weeks
Secondary outcomes (2)
Improvement in wound healing trajectory within 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.
Measured: 12 weeks
Improvement in wound healing for the patient to return to function over the 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytonics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gaetano J Scuderi, MD, Study director, Cytonics Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209662
- Sponsor's protocol ID
- Cyt201-01
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02209662
- Acronym / sponsor ID
- Cyt201-01
- Conditions
- Diabetic Foot Ulcer
- Keywords
- APIC-PRP, Chronic Wounds, Diabetic foot ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Cytonics CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 6 Aug 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APIC-PRP and Standard of Care | Experimental | Device: APIC-PRPAPIC-PRP |
| Placebo, Saline plus standard of care | Placebo comparator | Other: Placebo, Saline plus standard of carePlacebo, Saline plus standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| APIC-PRPAPIC-PRP | Device | APIC-PRP and Standard of Care |
| Placebo, Saline plus standard of carePlacebo, Saline plus standard of care | Other | Placebo, Saline plus standard of care |
Primary outcome
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.
2 secondary outcomes
Improvement in wound healing trajectory within 12 weeks
Time frame: 12 weeks
Improvement in wound healing for the patient to return to function over the 12 weeks
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
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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.
Gaetano J Scuderi, MD study director
Cytonics Corporation
Questions about this trial
What is this clinical trial studying?
A study testing APIC-PRP in people with Diabetic Foot Ulcer, run by Cytonics Corporation.
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 14 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: status not confirmed, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
Complete wound closure within 12 weeks (time frame: 12 weeks). 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 6 Aug 2014.